Recently Requested 483s

April 2018

District Inspection Date Firm Name
BLT-DO 4/20/2018 Aphena Pharma Solutions-Maryland LLC
CDER 4/3/2018 Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.
CDER 4/11/2018 Fresenius Kabi Deutschland GmbH
CDRH 4/5/2018 NINGBO HECAI MEDICAL EQUIPMENT CO. LTD.
CDRH 4/19/2018 Humanoptics Ag.
CHI-DO 4/6/2018 Sterling Pharmceutical Svcs
CHI-DO 4/13/2018 Plexus Corporation
CHI-DO 4/27/2018 Blue Sky Bio, LLC
DAL-DO 4/9/2018 United 1 International Laboratories, LLC
DAL-DO 4/20/2018 Guardian Pharmacy Services
DEN-DO 4/12/2018 LED Technologies, LLC
DEN-DO 4/12/2018 Neo Innovations, Inc.
DEN-DO 4/19/2018 Mytrex, Inc. dba Rescue Alert
DET-DO 4/6/2018 Global Isotopes LLC dba Zevacor Molecular
FLA-DO 4/10/2018 C2C Development, LLC
FLA-DO 4/12/2018 ADMA Biologics Inc.
FLA-DO 4/13/2018 Quasar Bio-Tech, Inc.
KAN-DO 4/6/2018 eScreen Inc
KAN-DO 4/12/2018 TJN Mfg Inc
KAN-DO 4/18/2018 DynaFlex Ltd
KAN-DO 4/19/2018 Q A Laboratories Inc
LOS-DO 4/3/2018 Chen Shwezin, Inc. dba Park Compounding Pharmacy
LOS-DO 4/20/2018 Cardinal Health 414, LLC
MIN-DO 4/2/2018 Nortech Systems, Inc.
MIN-DO 4/6/2018 Bell Pharmaceuticals, Inc
MIN-DO 4/18/2018 NorthStar Medical Radioisotopes, LLC
MIN-DO 4/18/2018 Fairview Compounding Phamacy
NOL-DO 4/10/2018 Reliance Mobility, LLC
NWE-DO 4/4/2018 pSivida Inc.
NWE-DO 4/4/2018 Mobius Imaging, LLC
NWE-DO 4/5/2018 Conseal International, Inc.
NWE-DO 4/11/2018 Prototype & Plastic Mold Company, Inc.
NWE-DO 4/12/2018 Sarepta Therapeutics, Inc.
NWE-DO 4/13/2018 Coherent, Inc.
NWE-DO 4/13/2018 Berkshire Sterile Manufacturing, Inc.
NWE-DO 4/19/2018 Beaver Visitec
NWE-DO 4/26/2018 Cirrus Healthcare Products, LLC
NYK-DO 4/10/2018 Bio Gen Technologies, Inc
NYK-DO 4/11/2018 Luitpold Pharmaceuticals, Inc.
NYK-DO 4/18/2018 PHARBEST Pharmaceuticals, Inc.
PHI-DO 4/6/2018 DNE LLC
SAN-DO 4/4/2018 Hand Biomechanics Lab Inc
SAN-DO 4/11/2018 ABCO Laboratories, Inc.
SAN-DO 4/19/2018 Anigan, Inc.
SEA-DO 4/2/2018 Tricol Biomedical, Inc.
SEA-DO 4/13/2018 Nutritional Laboratories International Inc.

 

March 2018

District Inspection Date Firm Name
ATL-DO 3/7/2018 BOV Solutions
BLT-DO 3/7/2018 Euclid Systems Corporation
BLT-DO 3/20/2018 Nutravail, LLC.
CDER 3/1/2018 Rhodia Poliamida e Especialidades Ltda.
CDER 3/2/2018 Hetero Drugs Ltd. - Unit 1
CDER 3/2/2018 Rohto Pharmaceutical Company, Ltd. (Ueno Plant)
CDER 3/2/2018 Sandoz GmbH
CDER 3/2/2018 AmLion Toothpaste Mfg Sdn
CDER 3/2/2018 Mylan Laboratories Limited, Speciality Formulation Facility
CDER 3/2/2018 HnG Co., Ltd.
CDER 3/6/2018 Hisun Pharmaceutical Hangzhou Co Ltd
CDER 3/6/2018 Auronext Pharma
CDER 3/9/2018 Saurav Chemicals Limited
CDER 3/9/2018 Bharat Pharma
CDER 3/14/2018 Samsung Biologics Co. Ltd.
CDER 3/16/2018 Eli Lilly Kinsale Ltd.
CDER 3/16/2018 Vamsi Labs Ltd
CDER 3/22/2018 Zhejiang Huazhou Pharmaceutical Co., Ltd.
CDER 3/22/2018 Glenmark Pharmaceuticals Ltd.
CDER 3/23/2018 Jabones Y Productos Especializados SA de CV
CDER 3/29/2018 Contract Pharmaceuticals Ltd.
CDRH 3/1/2018 Pega Medical Inc.
CDRH 3/1/2018 Fluoptics SAS
CDRH 3/8/2018 Mi Gwang Contact Lens Co., Ltd.
CDRH 3/8/2018 Actegy Limited
CDRH 3/22/2018 Schiller Medical
CIN-DO 3/1/2018 American Thermal Instruments Inc
CIN-DO 3/1/2018 GEM City Enginnering and Manufacturing Corporation
CIN-DO 3/8/2018 Amylin Ohio LLC
CIN-DO 3/13/2018 Vital Connections, Inc.
CIN-DO 3/15/2018 Checkpoint Surgical Inc
CIN-DO 3/16/2018 Gendron Inc.
CIN-DO 3/20/2018 Electro Cap International Inc
CIN-DO 3/21/2018 Sonogage Inc
DAL-DO 3/20/2018 University Of Texas MD Anderson Cancer Center
DEN-DO 3/1/2018 Zimmer Biomet Spine Inc.
DEN-DO 3/16/2018 Cardinal Health 414 LLC
DET-DO 3/6/2018 Arcamed LLC
DET-DO 3/15/2018 Greenwald Surgical Company, Inc.
DET-DO 3/23/2018 Renton Surgical, LLC
FLA-DO 3/1/2018 Belcher Pharmaceuticals, LLC
FLA-DO 3/1/2018 Pure Source LLC
FLA-DO 3/14/2018 Republic Spine, LLC
KAN-DO 3/1/2018 Surmasis Pharmaceutical
KAN-DO 3/2/2018 Grato Holdings, Inc.
KAN-DO 3/5/2018 Southwest Technologies Inc
KAN-DO 3/13/2018 Apollo Care
KAN-DO 3/20/2018 Fuller Industries, LLC
KAN-DO 3/22/2018 Primus Sterilizer Company LLC
LOS-DO 3/6/2018 The Micro Connection Enterprises, Inc. DBA Personal Care Performance Group
LOS-DO 3/9/2018 TECHNICHEM CORP
LOS-DO 3/13/2018 Product Packaging West, Inc.
LOS-DO 3/15/2018 Thibiant International, Inc.
LOS-DO 3/16/2018 Amgen, Inc.
LOS-DO 3/21/2018 NuCare Pharmaceuticals Inc
MIN-DO 3/7/2018 Sybaritic, Inc
MIN-DO 3/9/2018 Summit Medical, LLC
NOL-DO 3/9/2018 Exxon Mobil Chemical Company
NOL-DO 3/9/2018 CNMC Company, Inc.
NOL-DO 3/15/2018 Edge Biologicals Inc
NOL-DO 3/23/2018 rms Surgical, Inc.
NWE-DO 3/2/2018 Siemens Healthcare Diagnostics, Inc
NWE-DO 3/2/2018 New England Life Care, Inc.
NWE-DO 3/16/2018 Biosensics
NWE-DO 3/23/2018 Tower Laboratories, Ltd.
NWJ-DO 3/9/2018 ImClone Systems, LLC. d.b.a. Eli Lilly and Company
NYK-DO 3/8/2018 Varex Imaging Corporation
NYK-DO 3/8/2018 OptumHealth Care Solutions Inc.
NYK-DO 3/15/2018 Aqua Sciences Inc
NYK-DO 3/16/2018 Genalstrap Inc.
NYK-DO 3/22/2018 American Bio Medica Corp
NYK-DO 3/29/2018 Advanced Monitored Caregiving
NYK-DO 3/30/2018 Alliance Precision Plastics Corporation
SAN-DO 3/8/2018 Partell Specialty Pharmacy
SEA-DO 3/14/2018 The Feminina Group, Inc.
SJN-DO 3/23/2018 Caribe Holdings (Cayman) Co. Ltd dba PuraCap Caribe
ATL-DO 3/1/2018 David Stickler
CDER 3/23/2018 Michal Nowicki, Prof. Uniwersytecki Szpital Kliniczny NR 1
CIN-DO 3/30/2018 Sergio D. Bergese
KAN-DO 3/2/2018 Mazen M. Dimachkie, MD
LOS-DO 3/20/2018 Maria Greenwald, MD
MIN-DO 3/9/2018 Hardten, David R., MD, Clinical Investigator
MIN-DO 3/9/2018 Morie A. Gertz, M.D., Clinical Investigator
PHI-DO 3/9/2018 Giacomina Massaro-Giordano M.D.
SEA-DO 3/16/2018 Paul Nghiem

 

February 2018

District Inspection Date Firm Name
ATL-DO 2/2/2018 Hospira a Pfizer Company
CBER 2/2/2018 Baxalta Inc. Baxter AG
CDER 2/2/2018 DSM Nutritional Products GmbH
CDER 2/2/2018 Solupharm Pharmazeutische Erzeugnisse Gmbh
CDER 2/6/2018 Hanlim Pharm Co., Ltd.
CDER 2/8/2018 Katwijk Chemie Bv
CDRH 2/1/2018 Beijing Polycon Medical Engineering Ltd.
CDRH 2/1/2018 CL Medical
CDRH 2/8/2018 Dannoritzer Medizintechnik GmbH & Co. KG
CDRH 2/8/2018 Copious International Inc.
CDRH 2/8/2018 Beijing ADSS Development Co., Ltd.
CDRH 2/15/2018 Cair LGL
CHI-DO 2/7/2018 Physician Software Systems LLC
CIN-DO 2/2/2018 MHC Medical Products LLC
CIN-DO 2/14/2018 Patheon Pharmaceuticals Inc
CIN-DO 2/15/2018 Vantage Specialty Ingredients Inc
CIN-DO 2/22/2018 SPR Therapeutics Inc.
DAL-DO 2/6/2018 Monarch PCM, LLC
DAL-DO 2/16/2018 Insys Manufacturing, LLC
DEN-DO 2/6/2018 Natural Health Supply
DEN-DO 2/9/2018 Genesee BioMedical, Inc.
DEN-DO 2/16/2018 Yusef Manufacturing Laboratories, LLC
DEN-DO 2/16/2018 Wallsburg Farms Inc.
DET-DO 2/2/2018 Lannett Company Inc.
DET-DO 2/8/2018 THS International, Inc.
DET-DO 2/23/2018 Serim Research Corporation
FLA-DO 2/2/2018 Lexington International, LLC
FLA-DO 2/5/2018 Clearwater Colon Hydrotherapy, Inc.
KAN-DO 2/6/2018 PTI Union LLC
KAN-DO 2/8/2018 Morton Salt Inc
KAN-DO 2/23/2018 Veran Medical Technologies Inc
LOS-DO 2/2/2018 FNC Medical Corporation
LOS-DO 2/9/2018 Samson Pharmaceuticals, Inc
MIN-DO 2/2/2018 Alpha Source, Inc.
MIN-DO 2/2/2018 DeVere Company, Inc.
NOL-DO 2/1/2018 ProMED Concepts, LLC
NOL-DO 2/1/2018 The Compounding Pharmacy of America
NWE-DO 2/1/2018 Conair Corporation
NWE-DO 2/1/2018 Shire Human Genetic Therapies Inc
NWE-DO 2/1/2018 Sun Capsule Corporation
NWE-DO 2/2/2018 The Original Bradford Soap Works, Inc.
NWE-DO 2/8/2018 New England Life Care, Inc.
NWE-DO 2/21/2018 Fresh Pond Ventures, LLC
NWE-DO 2/23/2018 Brymill Corporation
NWE-DO 2/28/2018 Braintree Laboratories, Inc.
NWJ-DO 2/6/2018 Heritage Pharma Labs, Inc.
NYK-DO 2/1/2018 Transonic Systems Inc
NYK-DO 2/1/2018 Quicklook Inc
NYK-DO 2/2/2018 Geritrex Corp
NYK-DO 2/8/2018 Premier Heart, LLC
NYK-DO 2/16/2018 Gemini Pharmaceuticals, Inc.
PHI-DO 2/7/2018 Bio-pharm, Inc.
SAN-DO 2/1/2018 Alza Corporation
SAN-DO 2/1/2018 All Quality & Services, Inc.
SAN-DO 2/2/2018 Botanic Beauty Products, Inc.
SAN-DO 2/23/2018 NeuroField, Inc.
SEA-DO 2/7/2018 D. E. Hokanson, Inc.

 

January 2018

District Inspection Date Firm Name
CDER 1/11/2018 Tianjin Weijie Pharmaceutical Co., Ltd.
CDER 1/11/2018 Ningbo Liyuan Daily Chemical Products Co.
CDER 1/11/2018 Satya Deeptha Pharmaceuticals Limited
CDER 1/12/2018 Inner Mongolia Huashu Biological Technology Co., Ltd.
CDER 1/12/2018 Shandong Zouping Dazhan New Materials Co., Ltd.
CDER 1/19/2018 Indoco Remedies Limited (Plant I)
CDER 1/23/2018 Wasserburger Arzneimittelwerk GmbH
CDER 1/25/2018 Cipla Limited
CDRH 1/9/2018 BMC Medical Co., Ltd.
CDRH 1/12/2018 BMC (Tianjin) Medical Co., Ltd.
CDRH 1/16/2018 Carestream Health, Inc., Global R&D Center (Shanghai)
CDRH 1/18/2018 Fresenius Vial Sa
CDRH 1/18/2018 Covalon Technologies Inc.
CDRH 1/18/2018 BEIJING SINCOHEREN SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD
CDRH 1/18/2018 Jago-Pro Sp.Z O.O.
CHI-DO 1/10/2018 Weiman Products, LLC
CHI-DO 1/11/2018 Asahi Kasei Medical America, Inc
CHI-DO 1/17/2018 Waldmann Lighting USA
CIN-DO 1/4/2018 Endoprime Inc
CIN-DO 1/19/2018 Bio-Thesiometer USA
CIN-DO 1/26/2018 Teva Womens Health Inc
DAL-DO 1/12/2018 Sovereign Pharmaceuticals, LLC
DAL-DO 1/12/2018 Seno Medical Instrument Inc
DAL-DO 1/24/2018 Empower Clinic Services, LLC
DEN-DO 1/5/2018 UNITED STATES DEPT OF ENERGY
DEN-DO 1/5/2018 Value Plastics, Inc.
DEN-DO 1/12/2018 MBi Distributing Inc. dba MBi Nutraceuticals
DEN-DO 1/17/2018 College Pharmacy, Inc.
DEN-DO 1/29/2018 WAVi Co.
DET-DO 1/9/2018 Grind Guard Technologies, Llc
DET-DO 1/31/2018 R2 Diagnostics, Inc.
FLA-DO 1/17/2018 Oxygen Development Llc
FLA-DO 1/26/2018 Noven Pharmaceuticals, Inc.
MIN-DO 1/3/2018 Cornell Llc
MIN-DO 1/12/2018 Webb Business Promotions
NOL-DO 1/11/2018 Permobil Inc
NOL-DO 1/31/2018 Medegen Medical Products, LLC
NWE-DO 1/3/2018 Medtronic Navigation, Inc.-Littleton
NWE-DO 1/3/2018 Provent Sleep Therapy LLC
NWE-DO 1/10/2018 O2 Concepts, LLC
NWE-DO 1/11/2018 Cetro America
NWE-DO 1/18/2018 Bio2 Technologies Inc.
NWE-DO 1/26/2018 Bandwagon, Inc.
NWE-DO 1/29/2018 Boston Eye Design, LLC
NWJ-DO 1/5/2018 Austarpharma LLC
NWJ-DO 1/8/2018 Raritan Pharmaceuticals, Inc.
NWJ-DO 1/18/2018 Sunrise Pharmaceutical, Inc.
NYK-DO 1/11/2018 Ivoclar Vivadent, Inc.
NYK-DO 1/18/2018 Amneal Pharmaceuticals
NYK-DO 1/26/2018 Len-Ron Manufacturing Division of Aramis Inc.
PHI-DO 1/18/2018 American Dental Sleep Medicine, IP, LLC
SAN-DO 1/11/2018 Qview Medical, Inc.
SEA-DO 1/11/2018 Micro Current Technology, Inc.
SEA-DO 1/25/2018 Cortex Manufacturing Inc.
SEA-DO 1/25/2018 Shift Labs Inc
SJN-DO 1/26/2018 Pfizer Pharmaceuticals LLC

 

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