Recently Requested 483s

October 2018

District Inspection Date Firm Name
ATL-DO 10/2/2018 Avanos Medical, Inc.
ATL-DO 10/12/2018 O. R. Surgical Company Inc.
BLT-DO 10/5/2018 LC Technologies, Incorporated
BLT-DO 10/17/2018 Reflexonic, LLC
BLT-DO 10/26/2018 Granules Pharmaceuticals Inc
CDER 10/9/2018 Malladi Drugs & Pharmaceuticals Ltd.
CDER 10/12/2018 MSD International GmbH (Singapore Branch)
CDER 10/12/2018 Honour Lab Limited
CDER 10/16/2018 Reliance Life Sciences
CDER 10/16/2018 Gadea Biopharma S.L.
CDER 10/18/2018 Lupin Limited
CDER 10/19/2018 Tokyo Chemical Industry Co Ltd
CDER 10/19/2018 Tai Guk Pharm Co., Ltd., Buyeo branch
CDER 10/19/2018 Livzon Group (Ningxia) Pharmaceutical Co., Ltd.
CDER 10/24/2018 JO Cosmetics Co., Ltd.
CDER 10/26/2018 CKD Bio Corporation
CDRH 10/11/2018 D-Eye srl
CDRH 10/18/2018 RUA Medical (Prestwick)
CDRH 10/18/2018 RUA Medical (Irvine)
CDRH 10/26/2018 Unomedical s.r.o.
CHI-DO 10/15/2018 Rogan Corporation
CHI-DO 10/16/2018 Cortek Endoscopy Inc
CIN-DO 10/16/2018 Medical Soft Inc
DAL-DO 10/3/2018 Woodfield Pharmaceutical, LLC
DAL-DO 10/5/2018 Skeletal Kinetics, Llc
DAL-DO 10/11/2018 BioMed Laboratories, LLC.
DAL-DO 10/17/2018 Ocusoft Inc.
DAL-DO 10/25/2018 Nurse Assist, LLC
DEN-DO 10/11/2018 IPAX, Incorporated
DEN-DO 10/24/2018 Foothills Professional Pharmacy, LTD 
DET-DO 10/11/2018 Battle Creek Equipment Co.
DET-DO 10/25/2018 Specialty Manufacturing, Inc.
DET-DO 10/30/2018 Quadsil Inc
FLA-DO 10/16/2018 Acorn Stairlifts - Kingspointe Warehouse
FLA-DO 10/17/2018 EUSA Global, LLC dba Ecleris USA
FLA-DO 10/18/2018 Pro Skin Solutions, Inc.
FLA-DO 10/23/2018 Love Alchemy Llc
FLA-DO 10/24/2018 Beutlich Pharmaceuticals LLC
FLA-DO 10/25/2018 Promise Pharmacy, LLC
FLA-DO 10/26/2018 Cardinal Health 414, LLC
FLA-DO 10/26/2018 Sunlight Medical, Inc.
KAN-DO 10/5/2018 inx Medical
KAN-DO 10/23/2018 Stand Aid Of Iowa Inc
LOS-DO 10/3/2018 Standard Homeopathic Company
LOS-DO 10/11/2018 Evans Manufacturing
LOS-DO 10/11/2018 Algunas Inc., dba Woodland Hills Compounding Pharmacy
LOS-DO 10/22/2018 Fmk Labs
LOS-DO 10/31/2018 Thermogram Assessment Services
MIN-DO 10/4/2018 Monteris Medical Corp
MIN-DO 10/12/2018 Imaging Biometrics LLC
MIN-DO 10/26/2018 TrueBotanica, LLC
NWE-DO 10/3/2018 Summit Orthopedic Technologies, Inc.
NWE-DO 10/10/2018 Berkshire Sterile Manufacturing, Inc.
NWE-DO 10/17/2018 GTIMD LLC
NWE-DO 10/19/2018 Johnson Memorial Cancer Center
NWJ-DO 10/3/2018 Datascope Corp. 
NWJ-DO 10/12/2018 Prosec Protection Systems, Inc. 
NYK-DO 10/4/2018 LSI Solutions, Inc.
NYK-DO 10/5/2018 The Flexite Company
NYK-DO 10/9/2018 Topiderm Inc.
NYK-DO 10/9/2018 Acuity Polymers, Inc.
NYK-DO 10/23/2018 LC Medical Concepts, Inc
NYK-DO 10/25/2018 Comprehensive Telemedicine
PHI-DO 10/2/2018 American Contract Systems
PHI-DO 10/25/2018 Follett LLC
SAN-DO 10/10/2018 Dao Health
SAN-DO 10/18/2018 Sun Deep, Inc. dba Sun Deep Cosmetics
SAN-DO 10/29/2018 Jajco, Inc. DBA Anchor Drugs Pharmacy
SJN-DO 10/24/2018 Baxter Healthcare Corporation
SJN-DO 10/24/2018 Galephar Pharmaceutical Research Inc.


September 2018

District Inspection Date Firm Name
BLT-DO 9/12/2018 AcariaHealth Pharmacy, Inc.
BLT-DO 9/25/2018 Loop Plaza Pharmacy Company DBA Loop Compounding Pharmacy
BLT-DO 9/27/2018 FUJIFILM Wako Chemicals U.S.A. Corporation
CBER 9/14/2018 ALBA Bioscience Limited dba Quotient Biodiagnostics Inc.
CDER 9/1/2018 Vital Laboratories Pvt Ltd Plant II
CDER 9/6/2018 ATLAS R&D Inc
CDER 9/7/2018 PCAS
CDER 9/13/2018 Changzhou Ruiming Pharmaceuticals Co. Ltd.
CDER 9/13/2018 Kumho Dental Pharmaceutical Co., Ltd.
CDER 9/13/2018 Genic Co., Ltd.
CDER 9/14/2018 Sun Pharmaceutical Industries, Inc.
CDER 9/14/2018 Patheon Inc.
CDER 9/14/2018 Chr. Olesen Synthesis A/S
CDER 9/14/2018 China Ningbo Shangge Cosmetic Technology Corp.
CDER 9/14/2018 Jiangxi Long Life Bio-Pharmaceutical Co., Ltd
CDER 9/21/2018 Laboratoires Clarins
CDER 9/21/2018 SICOR Societa Italiana Corticosteroidi s.r.l.
CDER 9/28/2018 Dong Yuan Technology Co., Ltd.
CDRH 9/4/2018 Osteotec Limited
CDRH 9/6/2018 Hsiner Co., Ltd.
CDRH 9/6/2018 Fournitures Hospitalieres Industrie
CDRH 9/6/2018 aap Biomaterials, GmbH
CDRH 9/13/2018 Institut Virion/Serion Gmbh
CHI-DO 9/28/2018 Myerson LLC
CIN-DO 9/13/2018 Great Lakes Neurotechnologies Inc
CIN-DO 9/17/2018 DimcoGray Inc.
CIN-DO 9/24/2018 Frantz Medical Development Ltd
CIN-DO 9/26/2018 Surface Dynamics LLC
CIN-DO 9/27/2018 Kiltex Corporation
DAL-DO 9/6/2018 Microlight Corporation of America
DAL-DO 9/6/2018 EMIT Corporation
DAL-DO 9/13/2018 Alan Neuromedical Technologies
DAL-DO 9/21/2018 Footprint Medical, Inc.
DAL-DO 9/25/2018 Winfield Laboratories, Inc.
DAL-DO 9/28/2018 CareFusion 2200, Inc.
DEN-DO 9/11/2018 Tolmar Inc.
DEN-DO 9/17/2018 Zevex Incorporated (dba MOOG Medical Devices Group)
DEN-DO 9/18/2018 Thatcher Company
DEN-DO 9/19/2018 SPS National Labs-Tempe
DET-DO 9/10/2018 Symmetry Medical, Inc.
DET-DO 9/26/2018 Kennametal Stellite L.P.
FLA-DO 9/4/2018 Acorn Stairlifts Inc
FLA-DO 9/11/2018 Southeast Signal Inc.
FLA-DO 9/14/2018 AMMD Labs, LLC
FLA-DO 9/14/2018 Myolyn LLC
FLA-DO 9/20/2018 Debut Development, LLC
KAN-DO 9/6/2018 Primus Corporation dba Trinity Biotech
KAN-DO 9/19/2018 Accurate RX Pharmacy Consulting LLC
KAN-DO 9/19/2018 HomeChoice Partners, Inc. dba Bioscrip Infusion Services
KAN-DO 9/20/2018 Streck
KAN-DO 9/27/2018 Reed Pharmacy
LOS-DO 9/7/2018 Blue Cross Laboratories, Inc
LOS-DO 9/13/2018 MAST Biosurgery USA, Inc
LOS-DO 9/13/2018 BCG Medical Inc
LOS-DO 9/14/2018 Neutraderm Inc.
LOS-DO 9/17/2018 VicTorch Meditek, Inc
LOS-DO 9/26/2018 P&L Developments, LLC
LOS-DO 9/27/2018 Aurident Inc
LOS-DO 9/27/2018 MedisourceRx
LOS-DO 9/28/2018 Diasol Inc.
MIN-DO 9/6/2018 Medspira, Llc
MIN-DO 9/20/2018 Unipower Corp
NWE-DO 9/5/2018 Pharmasol
NWE-DO 9/7/2018 Ecometics, Inc.
NWE-DO 9/7/2018 Valeritas, Incorporated
NWE-DO 9/7/2018 Conformis, Inc.
NWE-DO 9/19/2018 Beekley Corporation
NWE-DO 9/20/2018 BG Medicine, Inc.
NWE-DO 9/25/2018 Sheffield Pharmaceuticals, LLC
NWJ-DO 9/27/2018 Pentax of America Inc
NYK-DO 9/11/2018 GlaxoSmithKline LLC
NYK-DO 9/13/2018 SPS Medical Supply Corporation
NYK-DO 9/14/2018 ULTRAtab Laboratories, Inc.
NYK-DO 9/14/2018 Kings Park Slope Inc
NYK-DO 9/26/2018 Nalge Nunc International Corporation
NYK-DO 9/26/2018 Circulatory Technology Inc
NYK-DO 9/26/2018 Hyperbaric Technologies Inc.
NYK-DO 9/28/2018 OndaMed Inc
PHI-DO 9/21/2018 KVK-Tech, Inc.
PHI-DO 9/25/2018 Allegheny Health Network Home Infusion, LLC
SAN-DO 9/14/2018 White House Pharmacy Inc. dba San Jose Compounding Pharmacy
SEA-DO 9/12/2018 21st Century Scientific Inc
SJN-DO 9/14/2018 Agropharma Laboratories Inc.


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