Recently Requested 483s

January 2016

District Inspection Date Firm Name
ATL-DO 1/12/2016 Duke University Medical Center, Carolinas Cord Blood
BLT-DO 1/5/2016 Best Medical International, Inc.
CDER 1/12/2016 Institutt For Energiteknikk
CDER 1/12/2016 Wockhardt Limited
CDER 1/15/2016 Shandong Lukang Pharmaceutical Co. Ltd.
CDER 1/15/2016 Cosma S.P.A.
CDER 1/19/2016 FACTA Farmaceutici S.p.A.
CDER 1/22/2016 Henan Lihua Pharmaceutical Co., Ltd.
CDER 1/29/2016 Synthokem Labs Private Limited
CDER 1/29/2016 Arch Pharmalabs Ltd.
CDER 1/29/2016 Teva Pharmaceutical Works Co. Ltd.
CDER 1/29/2016 Hainan Poly Pharm. Co., Ltd.
CDRH 1/13/2016 Yangzhou Qionghua Sports Goods Co., Ltd.
CDRH 1/14/2016 Hindustan Syringes & Medical Devices Ltd
CDRH 1/20/2016 Medsorb Dominicana, S.A.
CDRH 1/21/2016 Taizhou Xinkang Medical Materials Co., Ltd.
CDRH 1/22/2016 Acute Ideas (Huizhou) Co., Ltd.
CDRH 1/28/2016 LAUDA DR. R. WOBSER GMBH & CO. KG
DAL-DO 1/5/2016 Richard E. Colgin I, Ltd.
DAL-DO 1/8/2016 Sovereign Pharmaceuticals, LLC
DEN-DO 1/8/2016 Soma Access Systems LLC
DEN-DO 1/21/2016 Spectranetics Corporation
DET-DO 1/19/2016 Oxus America, Inc.
FLA-DO 1/12/2016 Ergoactives, Llc
FLA-DO 1/28/2016 American Catheter Corp
LOS-DO 1/8/2016 Cosmetic Laboratories Of America
LOS-DO 1/15/2016 Respironics California Inc
LOS-DO 1/22/2016 Boston Scientific Neuromodulation Corporation
NWE-DO 1/6/2016 Kinetic Instruments, Inc.
NWE-DO 1/6/2016 Rhode Island Novelty Inc.
NYK-DO 1/5/2016 Nova Health Systems Inc
NYK-DO 1/8/2016 C.R. Bard Inc.
NYK-DO 1/19/2016 Feinstein Institute for Medical Research (Radiochemistry)
NYK-DO 1/29/2016 Brookhaven National Labs
PHI-DO 1/21/2016 Dialysis Medical Solutions, LLC
SEA-DO 1/28/2016 ACUTE Innovations, LLC
SJN-DO 1/22/2016 Amgen Manufacturing Limited

 

December 2015

District Inspection Date Firm Name
ATL-DO 12/3/2015 Winder Laboratories LLC
ATL-DO 12/10/2015 Eisai Inc
ATL-DO 12/10/2015 Monarch Medical Technologies
ATL-DO 12/10/2015 Biogen US Corporation
ATL-DO 12/21/2015 Abc Compounding Company Inc
BLT-DO 12/3/2015 Medifocus, Inc.
BLT-DO 12/18/2015 Barr Laboratories, Inc. (div. Of Teva)
BLT-DO 12/18/2015 American Antibiotics, Inc.
CDER 12/3/2015 Chifeng Pharmaceutical Company, Ltd.
CDER 12/3/2015 Nippon Kayaku Co., Ltd.
CDER 12/3/2015 Pan Drugs Limited
CDER 12/4/2015 Temmler Pharma GmbH & Co. KG
CDER 12/4/2015 Asahi Glass Company, Limited
CDER 12/4/2015 Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd.
CDER 12/4/2015 Actavis U.K. Ltd.
CDER 12/4/2015 Hanacos Co., Ltd.
CDER 12/7/2015 Azico Biophore India Private Limited
CDER 12/10/2015 Jubilant HollisterStier General Partnership
CDER 12/11/2015 Mitsubishi Tanabe Pharma Factory Ltd.
CDER 12/11/2015 Yonsung Fine Chemicals Co Ltd
CDER 12/11/2015 Softech Pharma Pvt. Ltd.
CDER 12/11/2015 Rubicon Research Private Limited
CDER 12/15/2015 Wockhardt, Ltd.
CDER 12/17/2015 Jubilant Draximage Inc
CDER 12/18/2015 Synthesia, a.s.
CDER 12/18/2015 Srikem Laboratories Pvt. Ltd.
CDRH 12/2/2015 Rainbow Specialty & Health Products
CDRH 12/4/2015 Medtronic International Trading Sarl
CDRH 12/8/2015 ZEPHYR SLEEP TECHNOLOGIES INC.
CDRH 12/10/2015 Sanofi-Aventis Deutschland GmbH
CDRH 12/10/2015 Uzinmdicare Co.
CDRH 12/10/2015 ABMEDICA SAS
CDRH 12/11/2015 Starfish Product Engineering Inc.
CDRH 12/16/2015 priMED Medical Products Inc.
CDRH 12/17/2015 V. Guldmann A/S
CDRH 12/17/2015 F.P. Rubinstein Y Cia SRL
CDRH 12/17/2015 Blue Ortho
CDRH 12/18/2015 The Hygenic Corporation
CHI-DO 12/21/2015 Renner & Co
CIN-DO 12/9/2015 Camco Chemical Company
DAL-DO 12/14/2015 Austin Pharma LLC
DAL-DO 12/29/2015 Dougherty's Pharmacy
DEN-DO 12/2/2015 Adapta Medical, Inc.
DEN-DO 12/4/2015 Myriad Genetics Laboratories, Inc.
DET-DO 12/9/2015 Biomedix, Inc.
DET-DO 12/11/2015 Summit Mfg. & Machining, Inc.
DET-DO 12/17/2015 Haven Innovation, Inc.
FLA-DO 12/3/2015 Alicia Diagnostics, Inc.
FLA-DO 12/4/2015 Encompas Unlimited, Inc.
FLA-DO 12/7/2015 US Stem Cell Clinic LLC
FLA-DO 12/10/2015 Jack P. Herick, Inc. dba Glades Drugs
FLA-DO 12/14/2015 SHL Pharma LLC
FLA-DO 12/18/2015 International Medical Industries, Inc.
FLA-DO 12/22/2015 IsoAid, L.L.C.
LOS-DO 12/11/2015 DLC Laboratories, Inc
LOS-DO 12/11/2015 Zest Anchors LLC
LOS-DO 12/11/2015 Genlabs Corporation
LOS-DO 12/15/2015 Stevenson Industries Inc
LOS-DO 12/16/2015 Iris Diagnostics
LOS-DO 12/21/2015 Padtest, LLC
LOS-DO 12/22/2015 Universal Packaging Systems, Inc.
MIN-DO 12/4/2015 Mayo Clinic Pet Radiochemistry Facility (MCPRF)
MIN-DO 12/22/2015 Morton Drug Company dba Morton LTC
NOL-DO 12/18/2015 Nashville Surgical Instruments, LLC
NWE-DO 12/11/2015 Dermapac, Inc.
NWJ-DO 12/9/2015 L'Oreal USA Products Inc
NWJ-DO 12/16/2015 Hovione LLC
NYK-DO 12/2/2015 Advance Pharmaceutical Inc
NYK-DO 12/9/2015 Professional Disposables International, Inc.
NYK-DO 12/14/2015 Misonix, Inc.
NYK-DO 12/22/2015 Buffalo Dental Manufacturing Co., Inc.
SAN-DO 12/3/2015 G S Cosmeceutical USA Inc
SAN-DO 12/7/2015 Cs Bio Company
SEA-DO 12/4/2015 Vanguard EMS, Inc.
SEA-DO 12/18/2015 SweetSpot Diabetes Care, Inc.

 

November 2015

District Inspection Date Firm Name
ATL-DO 11/9/2015 Medical Specialties Inc
BLT-DO 11/3/2015 PARI Respiratory Equipment, Inc.
BLT-DO 11/6/2015 WES Pharma Inc.
CBER 11/6/2015 Novo Nordisk A/S
CDER 11/5/2015 Les Importations Herbasante Inc.
CDER 11/6/2015 Merck Serono SA Aubonne
CDER 11/6/2015 Crystal Claire Cosmetics Inc.
CDER 11/6/2015 Eckert & Ziegler Radiopharma GmbH
CDER 11/6/2015 Ind-Swift Laboratories Limited
CDER 11/10/2015 Enaltec Labs Private Limited
CDER 11/11/2015 Beyond Technology Corporation Nanchang
CDER 11/13/2015 Patheon Inc. - Toronto Region Operations
CDER 11/13/2015 Boehringer Ingelheim Pharma Gmbh & Co Kg
CDER 11/13/2015 Avmor
CDRH 11/3/2015 Aussimed Ltd
CDRH 11/4/2015 Endosmart Gesellschaft fuer Medizintechnik mbH
CDRH 11/4/2015 Meinntech Co Ltd
CDRH 11/5/2015 KeyMed (Medical and Industrial Equipment) Ltd.
CDRH 11/5/2015 Cedic S.r.l.
CDRH 11/5/2015 Famidoc Technology Co., Ltd.
CDRH 11/5/2015 Longfian Scitech Co. Ltd.
CDRH 11/5/2015 STERIPACK MEDICAL POLAND SP. Z O. O.
CDRH 11/5/2015 R & L Co., Ltd
CDRH 11/11/2015 Helica Instruments, Ltd.
CDRH 11/11/2015 tic Medizintechnik GmbH & Co. KG
CDRH 11/12/2015 FIAB spa
CDRH 11/13/2015 Berwickshire Electronic Manufacturing Ltd.
CDRH 11/18/2015 German Medical Engineering GmbH
CDRH 11/19/2015 Medical Measurement Systems B.V.
CDRH 11/20/2015 Askion Gmbh
CDRH 11/26/2015 AdvaLight APS
CHI-DO 11/19/2015 Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy
CIN-DO 11/4/2015 Innovative Sterilization Technologies LLC
DAL-DO 11/17/2015 Mary Kay, Inc
DEN-DO 11/12/2015 Chandler Industries- Arrow Division
DEN-DO 11/18/2015 Marker Medical, LLC
FLA-DO 11/2/2015 Affordable Healthcare Solutions 1, LLC
FLA-DO 11/5/2015 Horizon Pharmaceuticals, Inc.
FLA-DO 11/6/2015 Product Quest Manufacturing LLC
FLA-DO 11/6/2015 Isolux, LLC
FLA-DO 11/12/2015 Cardinal Health
FLA-DO 11/16/2015 Epiderma Inc
FLA-DO 11/19/2015 Tropical Seas, Inc.
FLA-DO 11/19/2015 Practica Medical Manufacturing, Inc
FLA-DO 11/19/2015 Salt Chamber, LLC
KAN-DO 11/5/2015 AssayPro
LOS-DO 11/2/2015 Diamond Wipes International, Inc.
LOS-DO 11/5/2015 Auro Pharmacies, Inc.
LOS-DO 11/10/2015 Cosmoceutical Research Center, Inc.
LOS-DO 11/12/2015 Apnea Sciences Corporation
LOS-DO 11/16/2015 Blaine Labs Inc
LOS-DO 11/17/2015 Weckerle Sales Corporation
LOS-DO 11/19/2015 Irvine Biomedical Inc, a St. Jude Medical Co.
LOS-DO 11/20/2015 Edwards Lifesciences, LLC
LOS-DO 11/23/2015 Discus Dental LLC
LOS-DO 11/30/2015 Lina Gale Inc.
NOL-DO 11/19/2015 LPI, Inc.
NWE-DO 11/5/2015 Next Health, LLC
NWJ-DO 11/2/2015 Diopsys, Inc.
NWJ-DO 11/3/2015 Petnet Solutions, Inc.
NWJ-DO 11/19/2015 Cetylite Industries, Inc.
NYK-DO 11/2/2015 Silarx Pharmaceuticals, Inc.
NYK-DO 11/2/2015 Comprehensive Telemedicine
NYK-DO 11/9/2015 DDC Technologies Inc
NYK-DO 11/9/2015 Ascent Pharmaceuticals, Inc.
NYK-DO 11/12/2015 Moss Tubes Inc.
PHI-DO 11/2/2015 QS Pharma, LLC
PHI-DO 11/20/2015 Central Admixture Pharmacy Services, Inc.
SAN-DO 11/5/2015 UCSF Radiopharmaceutical Facility
SAN-DO 11/13/2015 Pulsar Vascular Inc
SAN-DO 11/23/2015 Thoratec Corporation
SEA-DO 11/2/2015 Biodynamics Corporation
SEA-DO 11/3/2015 TZ Medical, Inc.
SEA-DO 11/10/2015 Sensor Medical Technology, LLC
SEA-DO 11/23/2015 RevMedx, Inc.
SJN-DO 11/17/2015 Zimmer Manufacturing B.V.
SJN-DO 11/20/2015 TAPI Puerto Rico, Inc.

 

October 2015

District Inspection Date Firm Name
ATL-DO 10/15/2015 PETNET Solutions, Inc.
BLT-DO 10/7/2015 Cape Apothecary, Inc.
BLT-DO 10/9/2015 Shikani Medical, LLC dba The Airway Company
CBER 10/9/2015 CSL Behring Pty Ltd
CDER 10/7/2015 piCHEM Forschungs- und Entwicklungs GmbH
CDER 10/9/2015 Abbvie SRL
CDER 10/9/2015 Apotek Produktion & Laboratorier AB
CDER 10/9/2015 Moehs Cantabra, S.L.
CDER 10/9/2015 Rampex Labs Pvt., Ltd.
CDER 10/13/2015 Apotek Produktion & Laboratorier AB
CDER 10/16/2015 Interpharm Praha A.S.
CDER 10/16/2015 Aizant Drug Research Solutions Pvt. Ltd.
CDER 10/16/2015 Sesderma SL
CDER 10/22/2015 Dishman Pharmaceuticals & Chemicals Ltd.
CDER 10/23/2015 Farmabios, S.p.A.
CDER 10/23/2015 Optimus Generics Limited
CDER 10/27/2015 Wasserburger Arzneimittelwerk GmbH
CDRH 10/8/2015 DMP Ltd.
CDRH 10/8/2015 Kyowa Seiko Co Ltd
CDRH 10/14/2015 Applied BioPhotonics Ltd.
CDRH 10/15/2015 Lightmed Corporation
CDRH 10/15/2015 Won Industry Co.
CDRH 10/22/2015 Galemed Corporation
CDRH 10/29/2015 Minta Medical Limited
CHI-DO 10/16/2015 Bajaj Medical, LLC
CHI-DO 10/28/2015 American Pharmacy of Illinois, Inc. dba Alwan's Pharmacy
CIN-DO 10/8/2015 PETNET Solutions Inc
DAL-DO 10/8/2015 Goodier Cosmetics, LP
DAL-DO 10/8/2015 Allergan Sales, LLC
DAL-DO 10/9/2015 Downing Labs, LLC
DAL-DO 10/13/2015 Creative Fragrances, Ltd.
DAL-DO 10/23/2015 BASF Corporation
DET-DO 10/16/2015 Medivative Technologies, LLC
FLA-DO 10/2/2015 Sancilio & Company, Inc.
FLA-DO 10/14/2015 Miami Fat Supply, Inc
FLA-DO 10/20/2015 BioSculptor Corporation
FLA-DO 10/21/2015 Ward Photonics LLC
FLA-DO 10/26/2015 Theochem Laboratories, Inc.
FLA-DO 10/29/2015 Beutlich Pharmaceuticals LLC
FLA-DO 10/30/2015 Biomet Microfixation, LLC
KAN-DO 10/26/2015 Cramer Products Inc
LOS-DO 10/14/2015 Applied Medical Resources Corp
LOS-DO 10/16/2015 Packaging On Demand Inc
LOS-DO 10/23/2015 Dako North America Inc.
LOS-DO 10/26/2015 National Advanced Endoscopy Devices Inc
LOS-DO 10/30/2015 General Medical Company
LOS-DO 10/30/2015 NeoMPS, Inc.
NOL-DO 10/13/2015 Medical Center Pharmacy, Inc.
NOL-DO 10/23/2015 Medtronic Sofamor Danek USA Inc
NOL-DO 10/27/2015 Advanced Infusion Solutions
NOL-DO 10/27/2015 Bond Pharmacy, Inc. dba Advanced Infusion Solutions
NWE-DO 10/5/2015 Arthrosurface, Inc.
NWE-DO 10/5/2015 Genoa, a QoL Healthcare Company, LLC
NWE-DO 10/7/2015 MGM Instruments
NWE-DO 10/16/2015 Image Diagnostics, Inc.
NWE-DO 10/27/2015 Safecor Health, LLC
NWJ-DO 10/16/2015 Amneal Pharmaceuticals, LLC
NYK-DO 10/9/2015 ONY, Inc.
NYK-DO 10/30/2015 Safetec Of America Inc
PHI-DO 10/2/2015 SaveWay Compounding Pharmacy, Inc.
PHI-DO 10/22/2015 EMS Contract Packaging
SAN-DO 10/2/2015 Hamilton Medical, Inc.
SEA-DO 10/14/2015 EndoGastric Solutions, Inc.
SEA-DO 10/16/2015 MicroSurgical Technology, Inc.
SEA-DO 10/29/2015 Evergreen Orthopedic Research Lab, LLC dba Operativ
SJN-DO 10/22/2015 Gasco Industrial
SJN-DO 10/23/2015 Knoll LLC
SJN-DO 10/29/2015 Abbott Healthcare (Puerto Rico) Ltd.

 

September 2015

District Inspection Date Firm Name
ATL-DO 9/4/2015 King Bio Inc.
ATL-DO 9/4/2015 Qspex Technologies, Inc.
BLT-DO 9/14/2015 US Medical Innovations, LLC
CDER 9/3/2015 Aekyung Industrial Co. Ltd.
CDER 9/4/2015 Macfarlan Smith A Johnson Matthey Company
CDER 9/4/2015 Orchid Chemicals & Pharmaceuticals, Ltd.
CDER 9/8/2015 Hospira Healthcare India Pvt Ltd
CDER 9/9/2015 Laboratorios Kener, SA de CV
CDER 9/10/2015 Hysan Pharmaceutical Co., Ltd.
CDER 9/10/2015 Brightgene Pharmaceutical Co., Ltd.
CDER 9/11/2015 Dottikon Exclusive Synthesis AG
CDER 9/11/2015 Hubei Yidu Huayang Chemical Co.,Ltd
CDER 9/11/2015 Body Blue 2006, Inc.
CDER 9/15/2015 Laboratoire Unither
CDER 9/15/2015 Micro Labs Limited
CDER 9/17/2015 Lab-Service S.A.
CDER 9/18/2015 Actavis Italy S.p.A.
CDER 9/18/2015 Takeda Pharmaceutical Company Limited
CDER 9/18/2015 Laboratorios Lesvi, S.L.
CDER 9/18/2015 Gland Pharma Limited
CDER 9/25/2015 Parabolic Drugs Ltd
CDER 9/25/2015 Auronext Pharma
CDRH 9/3/2015 Shantou Chaonan Liangying Hegao Plastic Toy Factory
CDRH 9/4/2015 PaloDEx Group Oy
CDRH 9/4/2015 STERIPACK MEDICAL POLAND SP. Z O. O.
CDRH 9/10/2015 Josef Betzler Surgical Instruments e.K.
CDRH 9/10/2015 Bedfont Scientific, Ltd.
CDRH 9/10/2015 Meditop Bv
CDRH 9/10/2015 I-see Vision Technology Inc
CDRH 9/10/2015 Omega Laser Systems
CDRH 9/11/2015 Oculo-Plastik, Inc.
CDRH 9/11/2015 Wavelight GmbH
CDRH 9/11/2015 Ralco S.R.L.
CDRH 9/16/2015 Impeto Medical
CDRH 9/17/2015 Biomatlante
CDRH 9/17/2015 Bionen S.A.S.
CDRH 9/18/2015 Ellipse A/S
CDRH 9/18/2015 Eolane Vailhauques
CHI-DO 9/11/2015 Addition Technology
CHI-DO 9/16/2015 Best Value Ceramics
CHI-DO 9/23/2015 Del Medical, Inc.
CHI-DO 9/23/2015 Performance Health Systems LLC
CHI-DO 9/25/2015 Lights' Prosthetic Eyes Inc
CIN-DO 9/11/2015 PI Pharma Inc
CIN-DO 9/14/2015 RC Compounding Services, LLC
CIN-DO 9/29/2015 Kutol Products Co
DAL-DO 9/11/2015 Cosmetic Specialty Labs, Inc
DAL-DO 9/17/2015 Qualgen
DAL-DO 9/23/2015 CrystalBraces, LLC.
DAL-DO 9/23/2015 CrystalBraces, LLC.
DAL-DO 9/28/2015 Oxysure Systems, Inc.
DET-DO 9/2/2015 Engineered Medical Systems,Inc
DET-DO 9/15/2015 Cork Medical Products
DET-DO 9/21/2015 Centurion Medical Products Corporation
FLA-DO 9/3/2015 Sunlight Medical, Inc.
FLA-DO 9/4/2015 AcuLux, Inc.
FLA-DO 9/4/2015 American Contract Systems, Inc.
FLA-DO 9/9/2015 Kinetic Research, Inc.
FLA-DO 9/10/2015 Machine Laboratory Division Anjon
FLA-DO 9/11/2015 Miami Stem Cell Treatment Center
FLA-DO 9/16/2015 Nanotherapeutics, Inc.
FLA-DO 9/17/2015 South East Instruments Corp.
FLA-DO 9/18/2015 Clinical Diagnostic Solutions, Inc.
FLA-DO 9/18/2015 Therasage, LLC.
LOS-DO 9/2/2015 Ios Technologies Inc
LOS-DO 9/2/2015 Eisertech LLC
LOS-DO 9/3/2015 Chemtron Biotech Inc
LOS-DO 9/8/2015 Natren, Inc.
LOS-DO 9/8/2015 Irvine Stem Cell Treatment Center
LOS-DO 9/10/2015 Prescription Lab Compounding Pharmacy
LOS-DO 9/11/2015 Chen Shwezin, Inc. dba Park Compounding Pharmacy
LOS-DO 9/11/2015 InTouch Technologies Inc
LOS-DO 9/16/2015 Shadow Holdings, LLC
LOS-DO 9/17/2015 American Dent-all Inc
LOS-DO 9/17/2015 Blue Cross Laboratories, Inc
LOS-DO 9/17/2015 CMR Naviscan Corporation
LOS-DO 9/18/2015 IVD Research, Inc.
LOS-DO 9/18/2015 Apnea Sciences Corporation
LOS-DO 9/21/2015 University Rx Specialties Inc
LOS-DO 9/23/2015 Brident Inc
LOS-DO 9/25/2015 SynergEyes, Inc.
LOS-DO 9/28/2015 Cyber Medical Imaging Inc
LOS-DO 9/29/2015 Jones Drug Company, Inc. dba Reed's Compounding Pharmacy
MIN-DO 9/3/2015 Uriel Pharmacy, Inc
MIN-DO 9/18/2015 Miromatrix Medical Inc.
MIN-DO 9/21/2015 Sperian Eye & Face Protection, Inc
NOL-DO 9/16/2015 Orchid Orthopedic Solutions Alabama LLC
NOL-DO 9/23/2015 Coastal Meds, LLC.
NWE-DO 9/10/2015 Interactive Motion Technologies, Inc.
NWE-DO 9/14/2015 Conformis Inc.
NWE-DO 9/18/2015 Specialty Minerals, Inc.
NWE-DO 9/18/2015 Myriad Fiber Imaging Technologies, Inc.
NWE-DO 9/21/2015 Cosmedico Light Inc.
NWE-DO 9/21/2015 Medtronic Xomed, Inc.
NWJ-DO 9/28/2015 Medplast West Berlin, Inc
NWJ-DO 9/29/2015 Excelsior Medical Corp
NWJ-DO 9/29/2015 Wedgewood Village Pharmacy, Inc.
NYK-DO 9/30/2015 New York Blood Center, Inc.
PHI-DO 9/4/2015 Alex C. Fergusson, LLC
PHI-DO 9/18/2015 AEI Technologies, Inc
PHI-DO 9/18/2015 DrNaturalHealing Inc.
PHI-DO 9/21/2015 Johnson & Johnson Consumer Inc
PHI-DO 9/21/2015 Martech Medical Products, Inc.
PHI-DO 9/25/2015 Digestive Care Inc
PHI-DO 9/29/2015 Varitronics Inc
SAN-DO 9/3/2015 Chalgren Enterprises, Inc.
SAN-DO 9/3/2015 Lin-Zhi International Inc
SAN-DO 9/9/2015 Psi Health Solutions
SAN-DO 9/11/2015 Hologic, Inc.
SAN-DO 9/16/2015 Theranos, Inc.
SAN-DO 9/16/2015 Theranos, Inc.
SAN-DO 9/17/2015 Prime Herbs Corporation
SAN-DO 9/18/2015 Stryker Endoscopy
SAN-DO 9/18/2015 Grandpa's Compounding Pharmacy, Inc.
SAN-DO 9/23/2015 Skeletal Kinetics, Llc
SEA-DO 9/17/2015 Bend Research Pharmaceutical Process Development, Inc.
SEA-DO 9/30/2015 Mountain Spirit LLC dba Mountain Spirit Herbal Company
SJN-DO 9/3/2015 Patheon Puerto Rico, Inc.

 

August 2015

District Inspection Date Firm Name
ATL-DO 8/10/2015 Sterling Medical Inc.
ATL-DO 8/21/2015 United Therapeutics Corp.
ATL-DO 8/26/2015 Gulbrandsen Technologies
BLT-DO 8/20/2015 Phipps & Bird, Inc.
CDER 8/5/2015 Progela, S.A. de C.V.
CDER 8/6/2015 Deva Holding AS - Cerkezkoy Subesi
CDER 8/7/2015 Standard Chem & Pharm Co Ltd
CDER 8/7/2015 Neuland Laboratories Limited (Unit II)
CDER 8/7/2015 Cipla Limited
CDER 8/13/2015 Zhejiang Hisoar Pharmaceutical Co. Ltd.
CDER 8/13/2015 Sharon Bio-Medicine Limited
CDER 8/14/2015 USV Limited
CDER 8/14/2015 Acebright (India) Pharma Private Limited
CDER 8/21/2015 CSR COSMETIC SOLUTIONS INC.
CDER 8/28/2015 Laboratorios Sophia, S.A. De C.V.
CDRH 8/5/2015 Summit Medical Ltd.
CDRH 8/5/2015 Inmedico A/S
CDRH 8/6/2015 ARDO MEDICAL AG
CDRH 8/6/2015 Wenzhou Beipu Science & Technology Co., Ltd.
CDRH 8/6/2015 Electro-Therapeutic Devices, Inc.
CDRH 8/6/2015 Shenzhen Creative Industry Co Ltd
CDRH 8/6/2015 Shenzhen Zhiyuan Century Electric Appliances Co Ltd
CDRH 8/8/2015 Indica Chemical Industries
CDRH 8/12/2015 Rech AG
CDRH 8/20/2015 Changzhou Kanghui Medical Innovation Co., Ltd.
CHI-DO 8/4/2015 Philips Burton
CHI-DO 8/11/2015 Abbott Laboratories
CIN-DO 8/4/2015 DoubleDay Acquisitions LLC
CIN-DO 8/10/2015 The Keeper/ Moon Cup Inc.
CIN-DO 8/12/2015 GenPak Solutions LLC
CIN-DO 8/13/2015 Innovative Sterlization Technologies LLC
CIN-DO 8/19/2015 Vestibular Research and Development LLC dba balanceback
CIN-DO 8/31/2015 DiaPharma Group Inc
DAL-DO 8/6/2015 Walgreens Infusion Services
DAL-DO 8/7/2015 Carroll Company
DAL-DO 8/21/2015 Sovereign Pharmaceuticals, LLC
DAL-DO 8/21/2015 US Compounding Inc
DAL-DO 8/25/2015 General Chemical, LLC
DAL-DO 8/26/2015 ScienceLab.Com, Inc.
DAL-DO 8/26/2015 Naturich Labs Inc.
DAL-DO 8/27/2015 O.M. Performance, Inc. DBA PerSys Medical
DET-DO 8/4/2015 R2 Diagnostics, Inc.
DET-DO 8/5/2015 SURESTEP, LLC
DET-DO 8/26/2015 The Morel Company
DET-DO 8/27/2015 Innovative Surgical Designs
FLA-DO 8/13/2015 Anodyne Medical Device Inc. dba Tridien Medical
FLA-DO 8/13/2015 Gulf Fiberoptics, Inc.
FLA-DO 8/14/2015 Nephron Pharmaceuticals Corp.
FLA-DO 8/17/2015 Invivo Corporation
FLA-DO 8/18/2015 Ceragroup Industries Inc
FLA-DO 8/19/2015 XZeal Technologies, Inc.
FLA-DO 8/26/2015 Halkey Roberts Corp
FLA-DO 8/26/2015 Demetech Corp.
FLA-DO 8/27/2015 Winco Mfg., LLC
FLA-DO 8/27/2015 Innovative Therapies, Inc.
KAN-DO 8/10/2015 TELL Enterprises Inc
LOS-DO 8/3/2015 Advanced Vision Science Inc
LOS-DO 8/3/2015 Diasol Inc.
LOS-DO 8/6/2015 Ajinomoto Althea, Inc.
LOS-DO 8/10/2015 International Medication Systems Limited
LOS-DO 8/11/2015 Electromedical Technologies, LLC
LOS-DO 8/12/2015 Shine & Pretty USA Corporation
LOS-DO 8/17/2015 BIT Group
LOS-DO 8/18/2015 Talladium Inc
LOS-DO 8/18/2015 Pacific Healthcare, Inc dba B&B Pharmacy
LOS-DO 8/19/2015 Epitope Diagnostics Inc
LOS-DO 8/21/2015 Hospira, Inc.
LOS-DO 8/21/2015 Alliance Medical Products, Inc.
LOS-DO 8/28/2015 Evofem Inc.
LOS-DO 8/28/2015 Intra-Lock Manufacturing, Inc.
MIN-DO 8/3/2015 Mayo Clinic Pet Radiochemistry Facility (MCPRF)
MIN-DO 8/5/2015 R&D Batteries Inc
MIN-DO 8/7/2015 TreyMed, Inc.
MIN-DO 8/11/2015 ARB, LLC
NOL-DO 8/14/2015 UPM Pharmaceuticals
NOL-DO 8/19/2015 MicroPort Orthopedics Inc.
NOL-DO 8/20/2015 Diabetes Corporation of America dba DCA Pharmacy
NWE-DO 8/7/2015 N-Molecular Inc.
NWE-DO 8/7/2015 RI Consultants, LLC
NWE-DO 8/12/2015 Alexion Pharmaceuticals, Inc.
NWE-DO 8/13/2015 McNeil Healthcare, Inc.
NWE-DO 8/13/2015 Marel Corporation
NWJ-DO 8/12/2015 Tris Pharma Inc.
NYK-DO 8/6/2015 Estee Lauder Inc (Len Ron Mfg)
NYK-DO 8/7/2015 SMK Imaging LLC
NYK-DO 8/11/2015 Parkell, Inc.
NYK-DO 8/17/2015 Ondamed Inc
PHI-DO 8/17/2015 Gentell
PHI-DO 8/25/2015 Orasure Technologies
PHI-DO 8/27/2015 Johnson Matthey Inc. (dba Johnson Matthey Pharm. Materials)
SAN-DO 8/4/2015 Penumbra Inc.
SAN-DO 8/14/2015 Medical Instrument Development Laboratories, Inc.
SAN-DO 8/17/2015 Miramar Labs, Inc.
SAN-DO 8/20/2015 Sciton Inc.
SAN-DO 8/26/2015 Smith & Vandiver Corporation
SEA-DO 8/3/2015 Verathon, Inc.
SEA-DO 8/25/2015 Galena Biopharma, Inc.
SJN-DO 8/11/2015 Majopa Industries Corporation
SJN-DO 8/14/2015 Blu Caribe Inc
SJN-DO 8/17/2015 AIAC Internantional Pharma LLC

 

Page:     1     2     3     4     5     6