Recently Requested 483s
December 2020 |
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District | Inspection Date | Firm Name |
CDER | 12/4/2020 | Zhejiang Poly Pharm. Co., Ltd |
CDER | 12/4/2020 | Henan Yuchen Pharmaceutical Co., Ltd. |
CDER | 12/18/2020 | High Tech Pharm Co., Ltd. |
DAL-DO | 12/10/2020 | Lonza Houston, Inc |
LOS-DO | 12/1/2020 | ALIEN MILLING TECHNOLOGIES |
NWE-DO | 12/9/2020 | Cambridge Isotope Laboratories, Inc. |
DAL-DO | 12/21/2020 | Milind Javle, MD |
DEN-DO | 12/18/2020 | James K. Luu, MD |
KAN-DO | 12/17/2020 | Anuj Bhargava MD |
LOS-DO | 12/23/2020 | Samer K. Khaled, M.D. |
NWE-DO | 12/16/2020 | Caron Jacobson, Md |
NWJ-DO | 12/7/2020 | Eric D Whitman, MD |
PHI-DO | 12/29/2020 | Alison R. Sehgal, MD |
November 2020 |
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District | Inspection Date | Firm Name |
CDER | 11/16/2020 | Yichang Humanwell Oral Solid Dosage Plant |
CDER | 11/20/2020 | Shandong Anshun Pharmaceutical Co., Ltd. |
LOS-DO | 11/3/2020 | World Club Supply Corp |
NWE-DO | 11/2/2020 | Hopkinton Drug, Inc. |
NWE-DO | 11/3/2020 | Lonza Biologics, Inc. |
NWE-DO | 11/11/2020 | Lyophilization Services of New England, Inc. |
NWJ-DO | 11/5/2020 | Novel Laboratories, Inc. d.b.a LUPIN |
NYK-DO | 11/12/2020 | Advanced Monitored Caregiving, Inc. |
DEN-DO | 11/23/2020 | Marcello M. Rotta, MD |
DEN-DO | 11/24/2020 | Neil Sheth, MD |
LOS-DO | 11/13/2020 | Ronald B. Natale, MD |
NOL-DO | 11/20/2020 | Paul A. Goepfert, MD. |
SAN-DO | 11/16/2020 | Mark Adaimy MD |
SAN-DO | 11/25/2020 | Michael L. Levin, M.D. |
October 2020 |
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District | Inspection Date | Firm Name |
BLT-DO | 10/30/2020 | Pharmaceutics International, Inc. |
CDER | 10/30/2020 | Shandong Anhong Pharmaceutical Co., Ltd. |
CIN-DO | 10/7/2020 | Synapse Biomedical Inc |
DEN-DO | 10/7/2020 | CPAPNEA Medical Supply |
FLA-DO | 10/30/2020 | B. Braun Medical Inc. |
LOS-DO | 10/26/2020 | Medtronic Heart Valves Division |
NWE-DO | 10/27/2020 | Berkshire Sterile Manufacturing, Inc. |
NWJ-DO | 10/9/2020 | Millers of Wyckoff, Inc. |
NWJ-DO | 10/9/2020 | EHT Pharmacy LLC dba Curexa |
NWJ-DO | 10/16/2020 | US Pharmaceuticals Inc. |
NWJ-DO | 10/26/2020 | Quagen Pharma, LLC |
NYK-DO | 10/13/2020 | Ascent Pharmaceuticals, Inc. |
NYK-DO | 10/23/2020 | Viant AS&O Holdings, LLC |
NYK-DO | 10/28/2020 | Frostime Llc |
SEA-DO | 10/16/2020 | Juno Therapeutics Inc |
BLT-DO | 10/8/2020 | James L. Bicksel MD |
BLT-DO | 10/28/2020 | Bankole Johnson MD |
DAL-DO | 10/2/2020 | Joseph Thaddeus Beck, MD |
DAL-DO | 10/20/2020 | James S. Cochran, MD |
DAL-DO | 10/21/2020 | Jawad A. Qureshi MD |
LOS-DO | 10/13/2020 | Bailey, Timothy S., MD |
NYK-DO | 10/20/2020 | Eric Hollander MD |
PHI-DO | 10/21/2020 | Patricia Kropf MD |
SAN-DO | 10/14/2020 | Lawrence M. Lehrner MD |
SAN-DO | 10/16/2020 | Paul Harmatz, M.D. |
September 2020 |
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District | Inspection Date | Firm Name |
DAL-DO | 9/22/2020 | DFB Technologies, Ltd |
DEN-DO | 9/3/2020 | STAQ Pharma, Inc. |
DEN-DO | 9/16/2020 | Potter's House Apothecary, Inc |
DEN-DO | 9/17/2020 | Transtracheal Systems, Inc. |
DET-DO | 9/2/2020 | Catalent Indiana, LLC |
LOS-DO | 9/3/2020 | National Advanced Endoscopy Devices Inc |
LOS-DO | 9/4/2020 | Creative Essences Inc |
LOS-DO | 9/21/2020 | Kenlor Industries, Inc. |
LOS-DO | 9/30/2020 | Sky Systems Co., Inc. |
NWE-DO | 9/4/2020 | Genzyme Corporation |
NWE-DO | 9/16/2020 | J & J Instruments, LLC |
NWJ-DO | 9/3/2020 | Carnegie Pharmaceutical Llc |
NWJ-DO | 9/8/2020 | EYWA PHARMA INC |
NYK-DO | 9/22/2020 | ConMed Corporation |
NYK-DO | 9/24/2020 | Healthy Choice Compounding LLC |
SEA-DO | 9/23/2020 | Kelley-Ross & Associates, Inc. dba Kelley-Ross Compounding Pharmacy |
BLT-DO | 9/18/2020 | Ahmed Kaldun Nossuli M.D., Principal Investigator |
DAL-DO | 9/11/2020 | DR. NELSON E. UZQUIANO |
DEN-DO | 9/14/2020 | Michael J. Schurr, MD |
FLA-DO | 9/10/2020 | Saranya Chumsri MD |
FLA-DO | 9/29/2020 | Ignacio J. Rodriguez, MD |
LOS-DO | 9/2/2020 | Daniel Norman, M.D. |
LOS-DO | 9/25/2020 | Rafaelito S. Victoria, MD |
MIN-DO | 9/4/2020 | Robert M. Haws, M.D. |
NOL-DO | 9/16/2020 | Trevor Pickering MD |
NYK-DO | 9/2/2020 | Amit Garg, M.D. |
PHI-DO | 9/28/2020 | Sigrid Blome-Eberwein |
SAN-DO | 9/18/2020 | Ari Baron MD |
August 2020 |
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District | Inspection Date | Firm Name |
DEN-DO | 8/13/2020 | Fresenius Medical Care, North America |
DEN-DO | 8/27/2020 | Vivos Therapeutics, Inc. |
NWE-DO | 8/25/2020 | Twincraft Inc. |
NWJ-DO | 8/10/2020 | AACE Pharmaceuticals, Inc. |
NWJ-DO | 8/18/2020 | Kobo Products, Inc |
NWJ-DO | 8/21/2020 | ImClone Systems, LLC. d.b.a. Eli Lilly and Company |
NWJ-DO | 8/21/2020 | Grant Industries, Inc. |
SEA-DO | 8/13/2020 | International Isotopes Inc. |
CIN-DO | 8/28/2020 | Elie Abu Jawdeh MD |
NWE-DO | 8/20/2020 | Monica E. Kleinman, M.D. |
July 2020 |
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District | Inspection Date | Firm Name |
BLT-DO | 7/10/2020 | Pharmaceutics International, Inc. |
CDER | 7/27/2020 | Bayer AG |
LOS-DO | 7/23/2020 | B. Braun Medical Inc |
SAN-DO | 7/24/2020 | UCSF Radiopharmaceutical Facility |
CHI-DO | 7/20/2020 | Kathleen M. Mullane, Clinical Investigator |
DEN-DO | 7/16/2020 | Karsh, Lawrence, M.D. |
SEA-DO | 7/17/2020 | George A. Diaz, M.D. |
SEA-DO | 7/23/2020 | Philip M. Bolton, M.D. |
June 2020 |
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District | Inspection Date | Firm Name |
NOL-DO | 6/23/2020 | IT Synergistics, LLC |
NYK-DO | 6/15/2020 | MasterPharm LLC |
FLA-DO | 6/23/2020 | Evelyn Lopez-Brignoni, M.D. |
SEA-DO | 6/3/2020 | Christina S. Baik, M.D. |
May 2020 |
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District | Inspection Date | Firm Name |
CHI-DO | 5/18/2020 | Fresenius Kabi USA LLC |
FLA-DO | 5/15/2020 | Allay Pharmaceuticals, LLC |
April 2020 |
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District | Inspection Date | Firm Name |
CDER | 4/3/2020 | Apollo Health And Beauty Care, Inc. |
LOS-DO | 4/6/2020 | CareFusion 303, Inc. |
MIN-DO | 4/8/2020 | Honeywell Safety Products |
NOL-DO | 4/9/2020 | Medical Center Pharmacy, Inc. |
NYK-DO | 4/3/2020 | Olaregen Therapeutix Inc. |
SJN-DO | 4/27/2020 | Romark Global Pharma, LLC |
March 2020 |
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District | Inspection Date | Firm Name |
ATL-DO | 3/9/2020 | Lifequest Creations LLC |
ATL-DO | 3/12/2020 | 410 Medical Inc. |
ATL-DO | 3/13/2020 | Winder Laboratories, LLC |
BLT-DO | 3/4/2020 | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. |
CBER | 3/4/2020 | Bioconnection BV |
CBER | 3/6/2020 | Broekman Institute |
CDER | 3/5/2020 | Reactimex S.A. de C.V. |
CDER | 3/5/2020 | Strides Pharma Science Limited |
CDER | 3/5/2020 | Dr. Reddy's Laboratories Limited |
CDER | 3/6/2020 | NATCO Pharma Limited |
CDER | 3/6/2020 | LEC Custom Products, Inc. |
CDER | 3/6/2020 | Megafine Pharma (P) Limited |
CDER | 3/6/2020 | TRUECARE BIOMEDIX |
CDER | 3/7/2020 | Solara Active Pharma Sciences Limited |
CDER | 3/13/2020 | Air Liquide Canada Inc. |
CDER | 3/13/2020 | Alembic Pharmaceuticals Limited |
CDER | 3/13/2020 | Ami Organics Pvt Ltd |
CDRH | 3/5/2020 | Creation Technologies LP |
CDRH | 3/5/2020 | Cavex Holland B.V. |
CDRH | 3/5/2020 | MatOrtho Ltd |
CDRH | 3/12/2020 | Karl Storz SE & Co. KG |
CHI-DO | 3/4/2020 | Thornton Industries, Inc. |
CHI-DO | 3/5/2020 | Dot International |
CHI-DO | 3/17/2020 | HNC Products Inc. |
CHI-DO | 3/18/2020 | Richard Wolf Medical Instruments Corp. |
CIN-DO | 3/13/2020 | National Biological Corp |
CIN-DO | 3/13/2020 | Steris Corporation |
CIN-DO | 3/17/2020 | Cosmax USA, Inc. |
DAL-DO | 3/6/2020 | Naturich Cosmetique Labs |
DAL-DO | 3/6/2020 | Empower Clinic Services, LLC |
DAL-DO | 3/9/2020 | Talon |
DAL-DO | 3/10/2020 | Unilever Manufacturing (US), Inc. |
DAL-DO | 3/13/2020 | Humco Holding Group, Inc |
DAL-DO | 3/13/2020 | Airway Management, Inc |
DAL-DO | 3/18/2020 | OHM Pharma, Inc. |
DEN-DO | 3/5/2020 | RLC Labs Inc. |
DEN-DO | 3/6/2020 | KBI Biopharma, Inc. |
DEN-DO | 3/10/2020 | Maruho Plastic Solutions dba Relucent Plastic Solutions |
DEN-DO | 3/20/2020 | OSO BioPharmaceuticals Manufacturing, LLC (AMRI) |
DET-DO | 3/12/2020 | CHEMATICS, INC. |
DET-DO | 3/19/2020 | LH Medical Corporation |
FLA-DO | 3/3/2020 | Amerx Healthcare Corp |
FLA-DO | 3/4/2020 | Kalitec Direct, LLC |
FLA-DO | 3/5/2020 | Pan Medical U.S. Corp |
FLA-DO | 3/6/2020 | CoreRx Inc. |
FLA-DO | 3/11/2020 | Llorens Pharmaceuticals International Division, Inc. |
FLA-DO | 3/13/2020 | BioSculptor Corporation |
FLA-DO | 3/16/2020 | The Medicine Shoppe Pharmacy |
KAN-DO | 3/4/2020 | Sigma-Aldrich Mfg LLC |
KAN-DO | 3/17/2020 | Chemisphere Corp |
KAN-DO | 3/19/2020 | Surmasis Pharmaceutical |
LOS-DO | 3/4/2020 | Shine & Pretty USA Corporation |
LOS-DO | 3/5/2020 | McKenna Labs Inc |
LOS-DO | 3/6/2020 | ONCORE - SAN MARCOS dba NEOTECH |
LOS-DO | 3/11/2020 | La Vita Compounding Pharmacy, LLC |
LOS-DO | 3/12/2020 | BALT USA, LLC |
LOS-DO | 3/18/2020 | TECHNICHEM CORP |
NOL-DO | 3/13/2020 | Chattem Plant 1 |
NWE-DO | 3/5/2020 | Concert Medical, LLC |
NWE-DO | 3/5/2020 | Mevion Medical Systems, Inc. |
NWE-DO | 3/6/2020 | Vaupell Molding and Tooling, Inc. |
NWE-DO | 3/16/2020 | Q Urological |
NWJ-DO | 3/11/2020 | Light Age, Inc. |
NWJ-DO | 3/13/2020 | Pacon Manufacturing Corporation |
NWJ-DO | 3/16/2020 | Speciality Pharma Manufacturing, LLC |
NWJ-DO | 3/20/2020 | Progenics Pharmaceuticals, Inc. |
NYK-DO | 3/3/2020 | Euromed, Inc. |
NYK-DO | 3/6/2020 | Ames Goldsmith Corporation |
NYK-DO | 3/6/2020 | Safetec Of America, Inc. |
NYK-DO | 3/9/2020 | Hitachi America, Ltd., Particle Therapy Division |
PHI-DO | 3/4/2020 | Alltrista Plastics, LLC |
PHI-DO | 3/13/2020 | Medical Products Laboratories, Inc. |
PHI-DO | 3/13/2020 | KVK-Tech, Inc. |
PHI-DO | 3/23/2020 | Devon MD LLC |
SAN-DO | 3/6/2020 | Intuitive Surgical, Inc. |
SAN-DO | 3/13/2020 | ABCO Laboratories, Inc. |
SEA-DO | 3/13/2020 | Acme United Corporation |
SEA-DO | 3/25/2020 | Philips North America LLC |
SJN-DO | 3/10/2020 | Caribe Holdings (Cayman) Co. Ltd dba PuraCap Caribe |
SJN-DO | 3/11/2020 | Becton Dickinson Caribe LTD |
CDER | 3/12/2020 | Jose Manuel Trigo Perez, M.D. |
CIN-DO | 3/13/2020 | Jessica Kaffenberger, M.D. |
DAL-DO | 3/3/2020 | Shannon R. Schrader, M.D. |
FLA-DO | 3/5/2020 | Adolfo Cueli MD |
February 2020 |
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District | Inspection Date | Firm Name |
ATL-DO | 2/3/2020 | Kesair Technologies, LLC |
ATL-DO | 2/6/2020 | PTI Royston LLC |
ATL-DO | 2/7/2020 | FMC Corporation FMC Lithium Division |
ATL-DO | 2/12/2020 | Family Pharmacy of Statesville |
ATL-DO | 2/18/2020 | Piedmont Hosp Inc |
BLT-DO | 2/6/2020 | Nutravail, LLC. |
BLT-DO | 2/20/2020 | Theragen, Inc |
BLT-DO | 2/28/2020 | Cosmetic Essence, LLC. |
BLT-DO | 2/28/2020 | Jubilant Cadista Pharmaceuticals, Inc. |
CBER | 2/18/2020 | CSL Behring Lengnau AG |
CBER | 2/18/2020 | Genzyme Polyclonals SAS |
CBER | 2/24/2020 | Omrix Biopharmaceuticals Ltd. |
CBER | 2/27/2020 | Millipore (U.K.) Ltd. |
CDER | 2/6/2020 | Sachem Europe BV |
CDER | 2/7/2020 | Terumo BCT Ltd |
CDER | 2/7/2020 | Pfizer Manufacturing Deutschland GmbH |
CDER | 2/7/2020 | Jetpharma SA |
CDER | 2/7/2020 | Sun Pharmaceutical Industries Limited |
CDER | 2/7/2020 | Unique Pharmaceutical Laboratories |
CDER | 2/7/2020 | Niagara Pharmaceuticals Inc |
CDER | 2/7/2020 | Neuland Laboratories Limited (Unit II) |
CDER | 2/7/2020 | Kreative Organics Private Limited |
CDER | 2/7/2020 | Mylan Laboratories Limited |
CDER | 2/7/2020 | TWI Pharmaceuticals, Inc. |
CDER | 2/7/2020 | Bakul Aromatics and Chemicals Private Limited |
CDER | 2/7/2020 | Sionc Pharmaceuticals Private Limited, Unit II |
CDER | 2/7/2020 | BioMylz Pvt. Ltd. |
CDER | 2/7/2020 | Skin Ecoguard S.A. de C.V. |
CDER | 2/11/2020 | Lupin Limited (Unit 1) |
CDER | 2/13/2020 | Recipharm Pharmaservices Private Limited |
CDER | 2/14/2020 | Macarthys Laboratories Limited dba Ethypharm |
CDER | 2/14/2020 | Hetero Drugs Ltd. - Unit 1 |
CDER | 2/14/2020 | Granules India Limited |
CDER | 2/14/2020 | Pharbil Waltrop Gmbh |
CDER | 2/14/2020 | Saraca Laboratories Limited |
CDER | 2/14/2020 | Galentic Pharma (India) Pvt. Ltd |
CDER | 2/18/2020 | Merck Serono SA Aubonne |
CDER | 2/19/2020 | Wintac Limited |
CDER | 2/20/2020 | Odan Laboratories Ltd |
CDER | 2/20/2020 | Aarti Industries Limited |
CDER | 2/20/2020 | Panacea Biotec Limited |
CDER | 2/20/2020 | Mayon'S Pharmaceuticals Pvt Ltd |
CDER | 2/21/2020 | Pillar5 Pharma Inc. |
CDER | 2/21/2020 | Aurobindo Pharma Ltd. |
CDER | 2/21/2020 | Alkem Laboratories Limited |
CDER | 2/21/2020 | Megafine Pharma (P) Limited |
CDER | 2/21/2020 | Chugai Pharma Manufacturing Co. Ltd. |
CDER | 2/21/2020 | Biocon Sdn Bhd |
CDER | 2/25/2020 | Nova Laboratories Limited |
CDER | 2/25/2020 | Rafarm S.A. |
CDER | 2/25/2020 | Shilpa Medicare Limited |
CDER | 2/26/2020 | Biocon Limited |
CDER | 2/28/2020 | Macco Organiques Inc. |
CDER | 2/28/2020 | Mylan Laboratories Ltd. (Unit 7) |
CDER | 2/28/2020 | Intas Pharmaceuticals Limited |
CDER | 2/28/2020 | Akorn AG |
CDER | 2/28/2020 | Mylan Laboratories Limited, Speciality Formulation Facility |
CDER | 2/28/2020 | Nartex Laboratorios Homeopaticos S.A. de C.V. |
CDER | 2/28/2020 | Cyan Labs S.A. de C.V. |
CDER | 2/28/2020 | Aurobindo Pharma Limited |
CDER | 2/28/2020 | VKT Pharma Private Limited |
CDRH | 2/6/2020 | Mego Afek AC Ltd. |
CDRH | 2/6/2020 | Aurolab |
CDRH | 2/6/2020 | Nitinol Devices and Components Costa Rica, S.R.L. |
CDRH | 2/6/2020 | Mi3 Limited |
CDRH | 2/6/2020 | Connectronics SRO |
CDRH | 2/13/2020 | Vision Science Co., Ltd. |
CDRH | 2/20/2020 | Diagam S.A. |
CDRH | 2/20/2020 | Bionen S.A.S. |
CDRH | 2/20/2020 | GBS Commonwealth Co., Ltd. |
CDRH | 2/27/2020 | Prodimed Plastimed Division |
CDRH | 2/27/2020 | OHIRA CO., LTD |
CDRH | 2/27/2020 | Huvexel Co. Ltd. |
CDRH | 2/27/2020 | BM KOREA CO., LTD. |
CDRH | 2/27/2020 | XIROS Ltd |
CDRH | 2/27/2020 | ST JUDE COSTA RICA LTDA. |
CHI-DO | 2/14/2020 | Luminex Corporation |
CHI-DO | 2/27/2020 | Stericycle Inc |
CHI-DO | 2/28/2020 | ISOVAC Products, LLC |
CIN-DO | 2/25/2020 | Klarity Medical Products LLC |
CIN-DO | 2/26/2020 | QED, Inc. |
CIN-DO | 2/28/2020 | Standard Textile Co Inc |
DAL-DO | 2/3/2020 | Ideal Implant Incorporated |
DAL-DO | 2/7/2020 | DPT Laboratories, Ltd |
DAL-DO | 2/10/2020 | Ansh Labs, LLC |
DAL-DO | 2/11/2020 | Morgan Newton Comp. |
DAL-DO | 2/11/2020 | Talon Pharmacy of Boerne |
DAL-DO | 2/20/2020 | NEXALIN TECHNOLOGY INC. |
DAL-DO | 2/21/2020 | Kalchem International, Inc. |
DAL-DO | 2/26/2020 | Solaris Pharmacy, Inc. |
DEN-DO | 2/7/2020 | Xeridiem Medical Devices, Inc. |
DEN-DO | 2/19/2020 | Abraxis Bioscience, LLC |
DEN-DO | 2/21/2020 | Cardinal Health 418, Inc. |
DEN-DO | 2/21/2020 | Avent, Inc. |
DEN-DO | 2/24/2020 | TOLMAR, Inc. |
DEN-DO | 2/26/2020 | Wells Johnson Company |
DET-DO | 2/7/2020 | Cook Inc. |
DET-DO | 2/11/2020 | ROMD, LLC |
DET-DO | 2/19/2020 | ContainMed, Inc. |
DET-DO | 2/25/2020 | Hudson Scientific LLC |
FLA-DO | 2/7/2020 | Cortez Drugs |
FLA-DO | 2/7/2020 | Clientele, Inc. |
FLA-DO | 2/12/2020 | Craftmatic Industries, Inc. |
FLA-DO | 2/20/2020 | Encore, Inc. |
FLA-DO | 2/24/2020 | Technological Medical Advancements LLC |
FLA-DO | 2/25/2020 | Baymar Solutions, LLC |
FLA-DO | 2/26/2020 | LUPIN RESEARCH INC. |
FLA-DO | 2/27/2020 | LifeSouth Community Blood Centers, Inc. |
FLA-DO | 2/27/2020 | Spinal Resources, Inc. |
FLA-DO | 2/28/2020 | Clerio Vision dba X-Cel Specialty Contacts |
FLA-DO | 2/28/2020 | Maitland Labs of Central Florida |
KAN-DO | 2/6/2020 | Primus Corporation |
KAN-DO | 2/6/2020 | S and B Pharma, Inc., dba Alkem Laboratories |
KAN-DO | 2/13/2020 | Grain Processing Corporation |
KAN-DO | 2/21/2020 | Reliable BiopharmaceuticalLLC |
LOS-DO | 2/3/2020 | Thibiant International, Inc. |
LOS-DO | 2/12/2020 | Kinamed Inc |
LOS-DO | 2/14/2020 | Soaptronic LLC |
LOS-DO | 2/20/2020 | Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy |
LOS-DO | 2/21/2020 | Vacumed, Div of Vacumetrics Inc |
LOS-DO | 2/21/2020 | Pegasus Research Corporation |
LOS-DO | 2/21/2020 | PETNET Solutions, Inc. |
LOS-DO | 2/28/2020 | Bausch & Lomb Incorporated |
MIN-DO | 2/13/2020 | Di-Chem Inc |
MIN-DO | 2/28/2020 | Creganna Medical |
NOL-DO | 2/12/2020 | Overton Brooks VA Medical Center |
NOL-DO | 2/13/2020 | Blount Discount Pharmacy, Inc. |
NOL-DO | 2/14/2020 | Owen Biosciences Inc. |
NOL-DO | 2/27/2020 | Techno-Aide Inc |
NOL-DO | 2/27/2020 | MRP, LLC |
NWE-DO | 2/6/2020 | Breas Medical, Inc. |
NWE-DO | 2/10/2020 | Bionik, Inc. |
NWE-DO | 2/10/2020 | Atrium Medical Corporation |
NWE-DO | 2/11/2020 | Renchel Tool LLC |
NWE-DO | 2/12/2020 | Lymol Medical Corporation |
NWE-DO | 2/14/2020 | Novo Nordisk US Bio Production Inc. |
NWE-DO | 2/19/2020 | Bio-Signal Group Corp. |
NWE-DO | 2/28/2020 | Covidien, LP |
NWJ-DO | 2/5/2020 | Ohm Laboratories Inc. |
NWJ-DO | 2/5/2020 | Pro-Blending LLC |
NWJ-DO | 2/12/2020 | Aurolife Pharma, LLC |
NWJ-DO | 2/13/2020 | Moldworks Worldwide LLC |
NWJ-DO | 2/25/2020 | Micro Stamping Corp |
NWJ-DO | 2/27/2020 | East Orange VA Medical Center |
NYK-DO | 2/5/2020 | SM Worldwide USA, Inc. |
NYK-DO | 2/6/2020 | Image Monitoring USA Inc |
NYK-DO | 2/7/2020 | Inova Lasers LLC |
NYK-DO | 2/11/2020 | Nasiff Associates, Inc |
NYK-DO | 2/11/2020 | Elite Medical Supply of New York, LLC |
NYK-DO | 2/12/2020 | Designs For Vision, INc. |
NYK-DO | 2/14/2020 | Treestone Trading Group LLC |
NYK-DO | 2/20/2020 | Oximeter Plus, Inc |
NYK-DO | 2/25/2020 | LC Medical Concepts, Inc |
NYK-DO | 2/28/2020 | Metropolis International LLC |
PHI-DO | 2/6/2020 | Blue Belt Technologies |
PHI-DO | 2/7/2020 | Isimac Machine Co Inc |
PHI-DO | 2/10/2020 | PhytogenX, Inc. |
SAN-DO | 2/12/2020 | Trigg Laboratories, Inc. dba Wet International |
SAN-DO | 2/13/2020 | Apical Instruments Inc |
SAN-DO | 2/13/2020 | LONZA HAYWARD |
SAN-DO | 2/21/2020 | MEDICREATIONS LLC |
SAN-DO | 2/27/2020 | Silk Road Medical Inc |
SEA-DO | 2/3/2020 | Modus Health, LLC |
SEA-DO | 2/13/2020 | US Vascular, LLC |
SEA-DO | 2/24/2020 | Northwest Cosmetic Laboratories LLC (DBA Elevation Labs Idaho) |
SEA-DO | 2/25/2020 | Cardinal Health 414, Inc. |
SEA-DO | 2/27/2020 | International Rehabilitative Sciences, Inc. |
SJN-DO | 2/20/2020 | Abbvie LTD |
SJN-DO | 2/26/2020 | MSD International GmbH (Puerto Rico Branch) LLC |
SJN-DO | 2/27/2020 | Amgen Manufacturing Ltd |
BLT-DO | 2/20/2020 | Robert Litman, M.D. |
CDER | 2/7/2020 | Rima Nabbout, M.D. |
CDER | 2/11/2020 | Bartosz Korczowski, M.D., PhD |
CHI-DO | 2/5/2020 | Sunandana Chandra MD, Clinical Investigaor |
CHI-DO | 2/28/2020 | William J. Gradishar, M.D. |
CIN-DO | 2/7/2020 | Dr. Manisha H Shah |
CIN-DO | 2/20/2020 | Wendell R. Miers, M.D. |
CIN-DO | 2/26/2020 | Ahmad (nmi) Shabsigh, MD |
CIN-DO | 2/28/2020 | Roman Skoracki MD |
DAL-DO | 2/10/2020 | Richard D. Guyer, MD |
FLA-DO | 2/26/2020 | Santosh M. Nair, MD |
LOS-DO | 2/4/2020 | Hessam Aazami, M.D. |
MIN-DO | 2/7/2020 | Nassr, Ahmad, MD |
MIN-DO | 2/28/2020 | Scott Okuno, M.D. |
NWE-DO | 2/21/2020 | Andrew A. Nierenberg, M.D. |
January 2020 |
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District | Inspection Date | Firm Name |
ATL-DO | 1/14/2020 | Sirona Dental, Inc. |
ATL-DO | 1/30/2020 | Perahealth Inc |
BLT-DO | 1/17/2020 | Granules Pharmaceuticals Inc |
BLT-DO | 1/31/2020 | BTE Technologies, LLC |
CDER | 1/10/2020 | Viva Pharmaceutical Inc |
CDER | 1/10/2020 | K Patel Phyto Extractions Pvt Ltd |
CDER | 1/10/2020 | Lupin Limited |
CDER | 1/10/2020 | Sun Pharmaceutical Industries Ltd |
CDER | 1/10/2020 | Haimen Pharma. Co., Ltd. |
CDER | 1/10/2020 | Maps Laboratories Private Limited |
CDER | 1/10/2020 | Zhejiang Benfor Biotech Co., Ltd. |
CDER | 1/14/2020 | The United Laboratories (Inner Mongolia) Co. Ltd. |
CDER | 1/14/2020 | Aerie Pharmaceuticals Ireland Limited |
CDER | 1/17/2020 | Church & Dwight Canada Corp. |
CDER | 1/17/2020 | IOI OLEO GMBH |
CDER | 1/17/2020 | Yuhan Chemical, Inc. |
CDER | 1/17/2020 | SMS Pharmaceutical Limited - Unit VII |
CDER | 1/17/2020 | Centaur Pharmaceuticals Private Ltd. |
CDER | 1/17/2020 | SK biotek |
CDER | 1/17/2020 | Lupin Limited |
CDER | 1/17/2020 | Novo Nordisk A/S |
CDER | 1/23/2020 | Asia Stabilizers Co., Ltd. |
CDER | 1/23/2020 | Emcure Pharmaceuticals Limited |
CDER | 1/24/2020 | Cosma S.P.A. |
CDER | 1/24/2020 | Sun Pharmaceutical Industries, Ltd. |
CDER | 1/24/2020 | Shashi Phytochemical Industries |
CDER | 1/24/2020 | Cipla Ltd. |
CDER | 1/24/2020 | Cenexi Laboratories Thissen SA |
CDER | 1/24/2020 | Aizant Drug Research Solutions Pvt. Ltd. |
CDER | 1/24/2020 | Chromo Laboratories India Private Limited |
CDER | 1/24/2020 | Biocon Limited (API) |
CDER | 1/28/2020 | Dalton Chemical Laboratories Inc. |
CDER | 1/28/2020 | Laboratorios Farmalan, S.A |
CDER | 1/31/2020 | Daito Pharmaceutical Co., Ltd. |
CDER | 1/31/2020 | Malladi Drugs & Pharmaceuticals Ltd. |
CDER | 1/31/2020 | Apotex Pharmachem India Pvt Ltd. |
CDER | 1/31/2020 | Acebright (India) Pharma Private Limited |
CDRH | 1/8/2020 | EPS Bio Technology Corp. |
CDRH | 1/9/2020 | Estar Technologies Ltd. |
CDRH | 1/9/2020 | Dong Guan Tanita Health Equipment Co., Ltd. |
CDRH | 1/9/2020 | Co-Innovation Biotect Co., Ltd. |
CDRH | 1/10/2020 | BK Meditech Co., Ltd. |
CDRH | 1/10/2020 | Aea Srl |
CDRH | 1/15/2020 | German Medical Engineering Gmbh |
CDRH | 1/16/2020 | Motion Concepts |
CDRH | 1/16/2020 | Citieffe Srl |
CDRH | 1/16/2020 | PixxGen Corporation |
CDRH | 1/17/2020 | Askion Gmbh |
CDRH | 1/17/2020 | HUREV Co., Ltd. |
CDRH | 1/21/2020 | National Therapy Products Inc. |
CDRH | 1/22/2020 | Dubourgel Grange SAS |
CDRH | 1/23/2020 | Transcoject GmbH |
CDRH | 1/23/2020 | Sooil Development Co., Ltd. |
CDRH | 1/23/2020 | Indus Medicare Limited |
CDRH | 1/23/2020 | Unisis Corp |
CDRH | 1/23/2020 | Citagenix Inc. |
CDRH | 1/29/2020 | Fritz Huber Medizintechnik |
CDRH | 1/29/2020 | MARVAO MEDICAL DEVICES LTD. |
CDRH | 1/30/2020 | Laboratorios Dentales De Zona Franca, S.A. |
CDRH | 1/30/2020 | Angiplast Private Limited |
CHI-DO | 1/17/2020 | Lattice Inc |
CHI-DO | 1/23/2020 | GD Group USA Co |
CHI-DO | 1/29/2020 | Immersivetouch Inc |
CIN-DO | 1/17/2020 | Abraham J & Phyllis Katz Cord Blood Foundation |
CIN-DO | 1/30/2020 | APS Materials, Inc. |
CIN-DO | 1/31/2020 | Invacare Corporation |
CIN-DO | 1/31/2020 | Xellia Pharmaceuticals USA LLC |
DAL-DO | 1/17/2020 | Eosera, Inc. |
DAL-DO | 1/22/2020 | Ramco Laboratories, Inc |
DAL-DO | 1/23/2020 | Bio Medical & Pharmaceutical Manufacturing Corp |
DAL-DO | 1/23/2020 | John L. McClellan Memorial Veterans Hospital |
DAL-DO | 1/24/2020 | Woodfield Pharmaceutical, LLC |
DAL-DO | 1/24/2020 | Claremore Compounding Center, Inc. |
DAL-DO | 1/24/2020 | AutoMedx, LLC |
DEN-DO | 1/6/2020 | Island Kinetics, Inc. d.b.a. CoValence Laboratories |
DEN-DO | 1/9/2020 | Neuromonics Inc. |
DEN-DO | 1/10/2020 | OraLabs, Incorporated |
DEN-DO | 1/17/2020 | Ultradent Products, Inc. |
DEN-DO | 1/28/2020 | Tolmar, Inc. |
DEN-DO | 1/29/2020 | 180 Innovations LLC |
FLA-DO | 1/8/2020 | Simple Diagnostics, Inc. |
FLA-DO | 1/17/2020 | Pedicraft, Inc. |
FLA-DO | 1/17/2020 | Genicon, Inc. |
FLA-DO | 1/17/2020 | Actavis Laboratories FL, Inc. |
FLA-DO | 1/21/2020 | AMS Diagnostics, LLC |
FLA-DO | 1/23/2020 | Macbrud Corporation |
FLA-DO | 1/23/2020 | Anodyne Therapy, LLC |
FLA-DO | 1/31/2020 | Exactech, Inc. |
KAN-DO | 1/16/2020 | Legacy Pharmaceutical Packaging LLC |
KAN-DO | 1/16/2020 | Apertus Pharmaceuticals |
KAN-DO | 1/16/2020 | NorthStar Medical Radioisotopes, LLC |
KAN-DO | 1/17/2020 | Hospira Inc |
KAN-DO | 1/24/2020 | Raining Rose Inc |
LOS-DO | 1/9/2020 | Scientific Pharmaceuticals, Inc. |
LOS-DO | 1/10/2020 | Respironics California, LLC |
LOS-DO | 1/14/2020 | GMP Laboratories of America Inc |
LOS-DO | 1/15/2020 | Pharma Tech Solutions, Inc |
LOS-DO | 1/17/2020 | Neodontics Inc |
LOS-DO | 1/17/2020 | Baxalta US Inc. |
LOS-DO | 1/23/2020 | Phamatech |
LOS-DO | 1/24/2020 | Vege-Kurl Inc |
LOS-DO | 1/24/2020 | A. R. Hinkel Company, Inc. dba R.A.Fischer |
LOS-DO | 1/28/2020 | Peerless Injection Molding, LLC |
LOS-DO | 1/29/2020 | Samson Pharmaceuticals, Inc |
LOS-DO | 1/30/2020 | K.C. Pharmaceuticals, Inc. |
LOS-DO | 1/30/2020 | BOX MEDICAL SOLUTIONS INC. |
MIN-DO | 1/10/2020 | Scientific Protein Laboratories, LLC |
MIN-DO | 1/30/2020 | Quality Blending, Inc |
NOL-DO | 1/10/2020 | Evonik Corporation |
NOL-DO | 1/22/2020 | Mid South Precision, Inc. |
NWE-DO | 1/9/2020 | Tecomet Inc. |
NWE-DO | 1/10/2020 | Bristol-Myers Squibb Company |
NWE-DO | 1/13/2020 | Tomy International Inc. |
NWE-DO | 1/13/2020 | Tecomet Inc. |
NWE-DO | 1/15/2020 | CutisPharma, Inc. |
NWE-DO | 1/27/2020 | MANCHESTER VA MEDICAL CENTER |
NWJ-DO | 1/22/2020 | Hovione LLC |
NYK-DO | 1/7/2020 | Harmonic Energetic Technologies Inc. |
NYK-DO | 1/8/2020 | DDC Technologies Inc. |
NYK-DO | 1/8/2020 | Frontier Therapeutics inc. |
NYK-DO | 1/10/2020 | Phamedica Inc. |
NYK-DO | 1/13/2020 | N-Molecular, Inc. dba SOFIE |
NYK-DO | 1/13/2020 | Saorsa Inc. |
NYK-DO | 1/15/2020 | Kem Medical Products Corp |
NYK-DO | 1/30/2020 | Spectronics Corp |
NYK-DO | 1/30/2020 | Surgical Design Corp |
NYK-DO | 1/30/2020 | American Australian Medical, Inc. |
NYK-DO | 1/31/2020 | ULTRAtab Laboratories, Inc. |
PHI-DO | 1/10/2020 | Vilvet Pharmaceuticals Inc. |
PHI-DO | 1/29/2020 | Abbey Color Incorporated |
SAN-DO | 1/10/2020 | Formulation Technology, Inc. |
SAN-DO | 1/10/2020 | Avantec Vascular Corporation |
SAN-DO | 1/16/2020 | Venus Concept Inc |
SAN-DO | 1/17/2020 | Olympus Corporation of the Americas |
SAN-DO | 1/17/2020 | Intarcia Therapeutics, Inc. |
SAN-DO | 1/28/2020 | Hahnemann Laboratories, Inc., dba Alpine Pharmaceuticals |
SAN-DO | 1/29/2020 | Columbia Cosmetics Manufacturing, Inc. |
SEA-DO | 1/10/2020 | Northwest Eye Design, LLC |
SEA-DO | 1/14/2020 | PatCen Healthcare Inc. |
SEA-DO | 1/23/2020 | Lacrimedics Inc |
SEA-DO | 1/27/2020 | Peripheral Visions, Inc. |
CDER | 1/24/2020 | Marina Nikanorova, M.D. |
CDER | 1/31/2020 | Piotr Wiland, MD |
DAL-DO | 1/10/2020 | Hans Lee, M.D. |
DAL-DO | 1/16/2020 | Daniel P Friedmann MD |
DEN-DO | 1/23/2020 | Ehrin J. Armstrong, MD |
FLA-DO | 1/16/2020 | Kalyan R. Bhamidimarri MD |
FLA-DO | 1/23/2020 | Blanca Gonzalez, M.D. |
KAN-DO | 1/21/2020 | Daniel M. Gruener, M.D. |
NWE-DO | 1/8/2020 | Benjamin Nwosu MD |
NWE-DO | 1/31/2020 | Wayne G. Shreffler, M.D. |
NWJ-DO | 1/10/2020 | Mandeep S. Oberoi, M.D. |
NWJ-DO | 1/13/2020 | Carlos Lastra MD |
NYK-DO | 1/8/2020 | Adilia M. Hormigo, M.D. |
NYK-DO | 1/21/2020 | Allan B. Perel, M.D. |
PHI-DO | 1/29/2020 | Gerard (nmi) Vockley, MD, PhD |