Recently Requested 483s

Untitled Document

January 2017

District Inspection Date Firm Name
ATL-DO 1/10/2017 Tripath Imaging, Inc.
ATL-DO 1/20/2017 H & A Walters Fulfillment Center LLC.
CDER 1/13/2017 Abbott AMO (Hangzhou) Co., Ltd.
CDER 1/13/2017 Ferring International Center S.A.
CDER 1/13/2017 Tai Heng Industry Co., Ltd.
CDER 1/13/2017 Neopharm Co. Ltd.
CDER 1/19/2017 Cosmax, Inc.
CDER 1/19/2017 Zhejiang Hisun Pharmaceutical Co., Ltd.
CDER 1/20/2017 Waterstone Pharmaceuticals Co., Ltd.
CDER 1/26/2017 European Perfume Works Co. LLC
CDER 1/27/2017 Amgen Singapore Manufacturing Pte L
CDRH 1/6/2017 Meko
CDRH 1/12/2017 Hebei Pukang Medical Instruments Co., Ltd.
CDRH 1/24/2017 Orvim SRL
CIN-DO 1/23/2017 KLC Services Inc
DAL-DO 1/12/2017 FUJIFILM Ultra Pure Solutions, Inc
DAL-DO 1/12/2017 South Texas Botanicals
DAL-DO 1/13/2017 MOORE'S COMPOUNDING PHARMACY
DAL-DO 1/30/2017 ZS Pharma, Inc.
DEN-DO 1/19/2017 In Your Atmosphere Holdings LLC
DET-DO 1/10/2017 Ascensia Diabetes Care U.S. Inc.
FLA-DO 1/11/2017 Med-Hot Thermal Imaging, Inc.
FLA-DO 1/13/2017 Xcelience, LLC
FLA-DO 1/25/2017 TG United, Inc.
KAN-DO 1/11/2017 Vi Jon, Inc.
KAN-DO 1/12/2017 Ulrich Medical USA Inc
KAN-DO 1/26/2017 Gary Wood
LOS-DO 1/12/2017 Trimed Inc
MIN-DO 1/4/2017 Augustine Biomedical & Design, LLC
NWE-DO 1/4/2017 Corflex, Inc.
NWE-DO 1/10/2017 Spine Wave, Inc.
NWE-DO 1/17/2017 Dielectrics, Inc.
NWE-DO 1/19/2017 Exergen Corporation
NWE-DO 1/25/2017 Cadence Science, Inc.
NWJ-DO 1/19/2017 Glatt Air Techniques, Inc.
NYK-DO 1/11/2017 Homeocare Laboratories, Inc.
NYK-DO 1/17/2017 Fonar Corporation
PHI-DO 1/19/2017 Gordon Laboratories
SEA-DO 1/12/2017 Vidco, Inc.
SEA-DO 1/18/2017 VPDiagnostics Inc

 

December 2016

District Inspection Date Firm Name
ATL-DO 12/2/2016 Bestcare, LLC
ATL-DO 12/14/2016 STERIMED, Inc.
ATL-DO 12/21/2016 medi Manufacturing Inc
BLT-DO 12/8/2016 Ohmeda Medical
BLT-DO 12/19/2016 Qiagen Sciences LLC
CDER 12/1/2016 South Pacific Sera Limited
CDER 12/1/2016 Sun Pharmaceutical Industries Ltd.
CDER 12/1/2016 Qinhuangdao Zizhu Pharmaceutical, Co.
CDER 12/2/2016 Aesica Pharmaceuticals GmbH
CDER 12/6/2016 Divi's Laboratories Ltd. (Unit II)
CDER 12/9/2016 Kothari Phytochemicals International
CDER 12/9/2016 Tongling Jieya Biological Technology Stock Co. Ltd.
CDER 12/13/2016 Pfizer Perth Pty Ltd.
CDER 12/14/2016 Xiamen Nature Caring Products Co Ltd
CDER 12/14/2016 Henan Kangdi Medical Devices Co. Ltd
CDER 12/16/2016 Apollo Health And Beauty Care
CDER 12/16/2016 Hetero Labs Limited Unit V
CDRH 12/1/2016 Master And Frank Enterprise. Co., Ltd.
CDRH 12/1/2016 Dio Medical Co. Ltd.
CDRH 12/8/2016 Molteno Ophthalmic Limited
CDRH 12/8/2016 The Binding Site Group, Ltd.
CDRH 12/8/2016 Panpac Medical Corporation
CDRH 12/8/2016 Alliance International Co., Ltd
CDRH 12/8/2016 Rudischhauser Surgical Instruments Manufacturing GmbH
CDRH 12/8/2016 Jiangsu Jumao Medical Equipment Co., Ltd.
CDRH 12/14/2016 FUJIFILM Techno Products Co. Ltd.
CDRH 12/15/2016 Tedec-Meiji Farma, S.A.
CDRH 12/15/2016 Headstar Medical Products Co., Ltd.
CDRH 12/15/2016 Hubei Haixin Protective Product Group Co., Ltd.
CDRH 12/22/2016 Okamoto Rubber Products Co., Ltd.
CHI-DO 12/13/2016 Prime Dental Manufacturing, Inc.
CIN-DO 12/2/2016 Rhinosystems Inc
CIN-DO 12/2/2016 CIL Isotope Separations, LLC
CIN-DO 12/7/2016 US Endoscopy Group Inc
CIN-DO 12/9/2016 Dick Medical Supply LLC
DEN-DO 12/8/2016 BLA Enterprises, LLC
DEN-DO 12/9/2016 Cerapedics, Inc.
DEN-DO 12/12/2016 CoRE labs, LLC
DET-DO 12/22/2016 TALEM TECHNOLOGIES LLC.
FLA-DO 12/6/2016 Biorep Technologies, Inc.
FLA-DO 12/9/2016 Acorn Stairlifts Inc
FLA-DO 12/13/2016 VistaPharm, Inc.
FLA-DO 12/13/2016 Command Medical Products, Inc.
KAN-DO 12/6/2016 Heartland Tanning Inc
KAN-DO 12/14/2016 Aire-Master of America Inc
KAN-DO 12/21/2016 Fundus Photo, LLC
LOS-DO 12/2/2016 University of Southern CA, DBA USC Molecular Imaging Center
LOS-DO 12/7/2016 International Medication Systems Limited
LOS-DO 12/8/2016 Lusys Laboratories, Inc.
LOS-DO 12/12/2016 Vita-Herb Nutriceuticals Inc
LOS-DO 12/16/2016 Strata Skin Sciences, Inc.
LOS-DO 12/23/2016 Vitaminerals, Inc.
NOL-DO 12/13/2016 Bayer Healthcare, LLC
NWE-DO 12/8/2016 Suture Concepts
NWE-DO 12/9/2016 OBP Medical Corporation
NWE-DO 12/13/2016 Tesco Associates, Inc.
NWJ-DO 12/5/2016 Actavis Elizabeth LLC
NWJ-DO 12/6/2016 Guardian Drug Co. Inc.
NYK-DO 12/2/2016 Ascent Consumer Products Inc.
NYK-DO 12/6/2016 Fallon Wellness Pharmacy, L.L.C.
NYK-DO 12/16/2016 Repro-Med Systems, Inc.
NYK-DO 12/21/2016 Jd888 Llc
NYK-DO 12/22/2016 Magellan Rx Pharmacy, LLC
PHI-DO 12/1/2016 Premier Medical Manufacturing
SAN-DO 12/13/2016 Bayer HealthCare, LLC
SEA-DO 12/7/2016 Kent Laboratories, Inc.

 

November 2016

District Inspection Date Firm Name
ATL-DO 11/4/2016 Avadim Technologies Inc.
ATL-DO 11/4/2016 The See Clear Company
ATL-DO 11/7/2016 Ablexan Corporation
BLT-DO 11/3/2016 Life Technologies Corporation
BLT-DO 11/8/2016 DT MedTech, LLC
CDER 11/3/2016 Guangzhou St Eva Fine Chemical Co. Ltd.
CDER 11/4/2016 Eli Lilly Italia SPA
CDER 11/11/2016 Aesica Queenborough Limited
CDER 11/11/2016 Ebewe Pharma Ges.m.b.H.Nfg. KG
CDER 11/11/2016 Suzhou Amerigen Pharmaceutical
CDER 11/18/2016 Teva Canada Limited
CDER 11/18/2016 Zhejiang Huahai Pharmaceutical Co., Ltd.
CDRH 11/3/2016 Medos Sarl
CDRH 11/4/2016 Eli Lilly Italia SPA
CDRH 11/10/2016 Jabil Circuit Singapore Pte Ltd
CDRH 11/10/2016 Fiagon GmbH
CDRH 11/10/2016 Fujirebio Europe NV
CDRH 11/18/2016 Roche Diagnostics GmbH
CDRH 11/18/2016 Creganna Medical Pte Ltd
CDRH 11/24/2016 Symmetry Medical Malaysia Sdn Bhd (758243-m)
CHI-DO 11/18/2016 Bion Enterprises Ltd.
CIN-DO 11/8/2016 Klarity Medical Products LLC
CIN-DO 11/9/2016 Criterion Tool & Die Inc
CIN-DO 11/10/2016 Teva Womens Health Inc
CIN-DO 11/16/2016 Percuvision Llc
CIN-DO 11/16/2016 Cardinal Spine
DAL-DO 11/10/2016 Sovereign Pharmaceuticals, LLC
DEN-DO 11/3/2016 NEBA Health LLC
DEN-DO 11/7/2016 KORR Medical Technologies, Inc.
DEN-DO 11/10/2016 Shippert Medical Technologies
DET-DO 11/10/2016 Contour Fabricators Inc
FLA-DO 11/1/2016 Dharma Research Inc
FLA-DO 11/10/2016 CoreRx Inc.
FLA-DO 11/15/2016 OMT, LLC
FLA-DO 11/17/2016 Medical Energy, Inc.
FLA-DO 11/18/2016 ECI Pharmaceuticals LLC
KAN-DO 11/28/2016 Hi-Dow International Inc
LOS-DO 11/10/2016 Illumina Inc. (Carroll Park facility)
LOS-DO 11/14/2016 Koros USA, Inc.
MIN-DO 11/10/2016 Cardiac Science Corporation
NOL-DO 11/3/2016 Preferred Medical Products Inc
NOL-DO 11/17/2016 Royal Precision Plastics
NWE-DO 11/4/2016 SRS Medical Systems Inc.
NWE-DO 11/9/2016 MIRA, Inc.
NWE-DO 11/15/2016 Diabetic Dabs Inc.
NWJ-DO 11/4/2016 Water-Jel Technologies, LLC
NWJ-DO 11/8/2016 InvaTech Pharma Solutions, LLC
NYK-DO 11/1/2016 Tangram Company Llc
NYK-DO 11/1/2016 Chartwell Pharmaceuticals LLC
NYK-DO 11/2/2016 Allegiant Health
NYK-DO 11/10/2016 Fougera Pharmaceuticals, Inc.
NYK-DO 11/18/2016 Intersurgical Inc
PHI-DO 11/29/2016 Standard Homeopathic Company
SAN-DO 11/2/2016 Depomed, Inc.
SAN-DO 11/8/2016 AMPAC Fine Chemicals LLC
SAN-DO 11/8/2016 Pulmonx, Corp.
SAN-DO 11/8/2016 Thayer Intellectual Property, Inc.
SEA-DO 11/4/2016 The Herbalist, Inc.
SJN-DO 11/16/2016 Cardinal Health PR 218 Inc
SJN-DO 11/18/2016 Bristol Myers Squibb Manufacturing Company
SJN-DO 11/28/2016 AMO Puerto Rico Manufacturing, Inc.

 

October 2016

District Inspection Date Firm Name
ATL-DO 10/5/2016 Bausch & Lomb Inc- Greenville Solutions Plant
BLT-DO 10/17/2016 Calwood Nutritionals, LLC.
BLT-DO 10/19/2016 AIV, Inc
CDER 10/3/2016 Star Lake Bioscience Co. Inc. Zhaoqing Guangdong
CDER 10/7/2016 Vijayasri Organics Ltd
CDER 10/14/2016 Dabur India Limited
CDER 10/18/2016 Vikshara Trading & Investments Ltd.
CDER 10/24/2016 Laboratorios Roldan S.A.
CDER 10/27/2016 Nifty Labs Pvt Ltd
CDER 10/28/2016 Caplin Point Laboratories Ltd
CDRH 10/13/2016 Planer PLC
CDRH 10/13/2016 Clement Clarke International, Ltd.
CDRH 10/13/2016 Shalon Chemical Industries Ltd.
CDRH 10/26/2016 Best Medical Canada
CIN-DO 10/25/2016 Pemco Inc
CIN-DO 10/26/2016 Nuvasive Inc
DAL-DO 10/7/2016 Phillips Co.
DAL-DO 10/14/2016 Cantrell Drug Company
DEN-DO 10/7/2016 dBMEDx, Inc
DEN-DO 10/12/2016 Nova Homeopathic Therapeutics Inc
DEN-DO 10/21/2016 Sontec Instruments, Inc
DEN-DO 10/21/2016 Inovar Inc
DET-DO 10/7/2016 Acumedia Manufacturers, Inc.
DET-DO 10/12/2016 Nice-Pak Products, Inc.
FLA-DO 10/5/2016 XZeal Technologies, Inc.
FLA-DO 10/21/2016 Oxygen Therapy Institute
FLA-DO 10/28/2016 Protech Professional Products, Inc.
KAN-DO 10/4/2016 Talk To Me Technologies
KAN-DO 10/12/2016 Hansen Ophthalmic Development Lab Inc
KAN-DO 10/25/2016 Care-Tech Laboratories, Inc.
MIN-DO 10/3/2016 Spectrum Plastics Group, Inc.
NOL-DO 10/3/2016 Precision Fabrics Group Inc.
NOL-DO 10/12/2016 Compass Health Brands Corp.
NOL-DO 10/13/2016 Cool Renewal LLC
NOL-DO 10/21/2016 Customer Service Associates, LLC
NWE-DO 10/4/2016 Corindus Inc
NWE-DO 10/14/2016 Tropical Products Inc
NWE-DO 10/18/2016 High Technology, Inc.
NWE-DO 10/20/2016 Cardiopulmonary Corporation
NWE-DO 10/20/2016 Bernoulli Enterprise, Inc.
NWE-DO 10/24/2016 Ninepoint Medical Inc.
NWE-DO 10/25/2016 Insulet Corporation
NWE-DO 10/25/2016 Beacon Prescriptions
NYK-DO 10/5/2016 Summit Research Labs, Inc.
NYK-DO 10/14/2016 American Cleaning Solutions
NYK-DO 10/27/2016 Cosco Enterprises Inc.
SAN-DO 10/7/2016 Cell Marque Corporation
SEA-DO 10/12/2016 United Contact Lens, Inc.
SJN-DO 10/3/2016 Baxter Healthcare Corporation
SJN-DO 10/3/2016 Warner Chilcott Company LLC
SJN-DO 10/7/2016 Becton Dickinson Caribe LTD

September 2016

District Inspection Date Firm Name
ATL-DO 9/16/2016 East Coast Oxygen & Hydro Testing Inc.
BLT-DO 9/6/2016 NovaSom, Inc.
BLT-DO 9/15/2016 Terumo Cardiovascular Systems Corporation
CDER 9/1/2016 Tianjin Tianyao Pharmaceuticals Co., Ltd
CDER 9/2/2016 Cosmetique Active Production
CDER 9/2/2016 Qilu Antibiotics (Linyi) Pharmaceutical Co. Ltd.
CDER 9/2/2016 Bath Concept Cosmetics (DongGuan) Co., Ltd.
CDER 9/2/2016 Tianjin Tianyao Pharmaceuticals Co., Ltd.
CDER 9/2/2016 Auropeptides
CDER 9/6/2016 Shashi Phytochemical Industries
CDER 9/7/2016 Patheon Italia S.P.A.
CDER 9/8/2016 Frike Cosmetic Ag
CDER 9/9/2016 Laboratoire de Biologie Vegetal Yves Rocher
CDER 9/9/2016 ILDONG PHARMACEUTICAL Co., Ltd.
CDER 9/14/2016 Mylan Laboratories Limited, (Nashik FDF)
CDER 9/14/2016 Shanghai Yinjing Medical Supplies Co., Ltd.
CDER 9/14/2016 Xinyu Pharmaceutical Co., Ltd.
CDRH 9/1/2016 Ashitaka Factory of Terumo Corporation
CDRH 9/2/2016 Gynetech PTY LTD
CDRH 9/7/2016 Jk Holding Gmbh
CDRH 9/8/2016 Narishige Co. Ltd
CHI-DO 9/26/2016 Anchor Products Company, Inc.
CHI-DO 9/27/2016 Medstrat, Inc.
CIN-DO 9/6/2016 Woodbine Products Co Inc
CIN-DO 9/7/2016 Natural Essentials Inc
CIN-DO 9/8/2016 Control Bionics
CIN-DO 9/16/2016 Crosbys Drugs Inc
DAL-DO 9/1/2016 MOORE'S PHARMACY INC
DAL-DO 9/14/2016 Healix Infusion Therapy, Inc.
DAL-DO 9/15/2016 Wal-Mart Optical Labs
DAL-DO 9/16/2016 Surgik LC
DET-DO 9/1/2016 Flotec, Inc.
DET-DO 9/7/2016 Panoramic Rental Corp.
FLA-DO 9/1/2016 Actigraph, LLC
FLA-DO 9/8/2016 Powers Medical Devices, LLC
FLA-DO 9/14/2016 Isolux, LLC
FLA-DO 9/28/2016 LAR NE, LLC
KAN-DO 9/14/2016 Aesculap Inc
LOS-DO 9/1/2016 LTW Tech LLC
LOS-DO 9/2/2016 CoValence, Inc.
LOS-DO 9/9/2016 Cianna Medical, Inc.
LOS-DO 9/9/2016 Crown Peak Industries, LLC
LOS-DO 9/15/2016 Icrco, Inc.
NOL-DO 9/2/2016 Mooney's Pharmacy, Inc.
NOL-DO 9/14/2016 Owen Biosciences Inc.
NOL-DO 9/14/2016 Advanced Breath Diagnostics, LLC dba Cairn Diagnostics
NWE-DO 9/1/2016 Data Innovations, LLC
NWE-DO 9/2/2016 Johnson Matthey Pharma Services
NWE-DO 9/8/2016 WCW, Inc.
NWE-DO 9/8/2016 Allurion Technologies, Inc.
NWE-DO 9/20/2016 Concert Medical, LLC
NWE-DO 9/21/2016 Codman & Shurtleff, Inc.
NWE-DO 9/23/2016 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
NYK-DO 9/1/2016 Valeant Pharmacueticals International
NYK-DO 9/2/2016 Accord Media, LLC
PHI-DO 9/7/2016 MTI Precision Products LLC.
SAN-DO 9/9/2016 Wei Laboratories, Inc.
SAN-DO 9/20/2016 Covidien, LLC
SEA-DO 9/19/2016 Precision Interconnect, LLC dba TE Connectivity Medical
SEA-DO 9/20/2016 Montana Compounding Pharmacy P.C.

 

August 2016

District Inspection Date Firm Name
ATL-DO 8/5/2016 Illumination Technologies, LLC
ATL-DO 8/5/2016 Absonutrix
BLT-DO 8/10/2016 FiberTech RoMack, Leoni Fiber Optics, Inc.
BLT-DO 8/17/2016 Agent Medical, LLC
CDER 8/5/2016 Shionogi Pharma Chemicals Co., Ltd.
CDER 8/5/2016 SHANDONG HAIYAN MEDICAL MANUFACTURE CO., LTD.
CDER 8/5/2016 Auronext Pharma
CDER 8/12/2016 3M Health Care, Ltd.
CDER 8/17/2016 Zhejiang Bangli Medical Products Co., Ltd
CDER 8/19/2016 Merro Pharmaceutical Co., Ltd.
CDER 8/19/2016 Lonza Guangzhou Nansha Ltd.
CIN-DO 8/1/2016 Devicor Medical Products Inc
CIN-DO 8/3/2016 Troy Innovative Instruments Inc
CIN-DO 8/12/2016 Western / Scott Fetzer Company
DAL-DO 8/5/2016 Chemtrade Solutions, LLC
DAL-DO 8/5/2016 Mindways Software, Inc.
DAL-DO 8/11/2016 Phillips Co.
DAL-DO 8/19/2016 Morton Salt Inc
DET-DO 8/2/2016 ROMD, LLC
FLA-DO 8/9/2016 Pharmatech LLC
LOS-DO 8/18/2016 World Club Supply Corp
LOS-DO 8/19/2016 Denttio, Inc.
NOL-DO 8/3/2016 Microtek Medical Inc
NOL-DO 8/3/2016 Remendium Labs, LLC
NWE-DO 8/3/2016 SRC Medical, Inc.
NWE-DO 8/3/2016 Hamilton Thorne, Inc
NWE-DO 8/4/2016 Pharmasol Corporation
NWE-DO 8/5/2016 Cirtec Medical Systems, LLC
NWE-DO 8/11/2016 Zyno Medical, LLC
NWE-DO 8/18/2016 Bio-Med Devices, Inc.
NWE-DO 8/26/2016 Renegade Wheelchairs, LLC
NWE-DO 8/31/2016 The Helping Hand Company Alliance LLC
NYK-DO 8/1/2016 Alexander Infusion LLC D/B/A Avanti Health Care
NYK-DO 8/9/2016 Amneal Pharmaceuticals
NYK-DO 8/10/2016 Aurora Labs, LLC
PHI-DO 8/1/2016 ImprimisRx Pharmacy LLC
PHI-DO 8/2/2016 Calumet Penreco LLC
PHI-DO 8/11/2016 Copperhead Chemical Company, Inc.
SAN-DO 8/1/2016 Miramar Labs, Inc.
SAN-DO 8/4/2016 Everglo Natural Veterinary Services, Inc.
SAN-DO 8/4/2016 Zevacor Pharma, Inc.
SEA-DO 8/22/2016 Breast Microseed Inc
SJN-DO 8/9/2016 Destileria Serralles, Inc.

 

Page:     1     2     3     4     5     6