Latest News

22 FDA CDER quality inspections posted in last 60 days

This is updated weekly with the latest FDA inspections.

Company City Country Inspection End Date Project Area Classification
Pfizer Pharmaceutica Barceloneta US 2019-12-20 Drug Quality Assurance VAI
Cadila Healthcare Li Ahmedabad IN 2019-12-20 Drug Quality Assurance NAI
MSN Laboratories Pri Sangareddy Sub-District IN 2019-12-20 Drug Quality Assurance NAI
Nihon Kolmar Co., Lt Unnan JP 2019-12-20 Drug Quality Assurance NAI
N-Molecular, Inc. db Colonie US 2020-01-13 Drug Quality Assurance VAI
Nelco Vet LLC dba Al Deer Park US 2020-01-06 Drug Quality Assurance NAI
Asept Pak Inc. Malone US 2019-12-20 Drug Quality Assurance VAI
Amneal Pharmaceutica Brookhaven US 2019-12-20 Drug Quality Assurance NAI
Biogenesis, Inc Paterson US 2020-01-17 Drug Quality Assurance NAI
Halo Pharmaceutical, Whippany US 2019-12-20 Drug Quality Assurance VAI
Strem Chemicals, Inc Newburyport US 2020-01-27 Drug Quality Assurance NAI
Boston Analytical, I Salem US 2020-01-24 Drug Quality Assurance VAI
Shire Human Genetic Lexington US 2020-01-15 Drug Quality Assurance NAI
Bristol-Myers Squibb Devens US 2020-01-10 Drug Quality Assurance VAI
Pharmalucence, Inc. Billerica US 2019-12-23 Drug Quality Assurance VAI
Natureplex LLC Olive Branch US 2019-12-20 Drug Quality Assurance VAI
International Medica South El Monte US 2019-12-20 Drug Quality Assurance NAI
Atlantic Biologicals Miami US 2020-01-14 Drug Quality Assurance VAI
Evonik Corporation Lafayette US 2020-01-16 Drug Quality Assurance NAI
FujiFilm Ultra Pure Carrollton US 2020-01-15 Drug Quality Assurance NAI
Teva Womens Health I Cincinnati US 2020-01-08 Drug Quality Assurance NAI
Catalent Pharma Solu Morrisville US 2019-12-20 Drug Quality Assurance NAI

WIZMED searches for the latest public 483s weekly.

MFG Country Date Link
Lupin Limited India 2020-01-17
Dr. Reddy's Laboratories Limited CTO Unit VI India 2020-01-28
Option Care Enterprises, Inc. dba Option Care Arkansas, USA 2019-12-20
Option Care Enterprises, Inc. dba Option Care Arkansas, USA 2019-12-20
ABC Pharmacy, Inc. California, USA 2019-12-20
Option Care Enterprises, Inc. dba Option Care Arkansas, USA 2019-12-20

Latest FDA warning letters below, this is updated weekly with the latest FDA warning letters.

Company Issue Date Office Link
VaporBreak 2020-02-06 Center for Tobacco Products
TP. Food Canning Ltd 2020-01-22 Center for Food Safety and Applied Nutrition (CFSAN)
Neptunus Seafood B.V 2020-01-22 Center for Food Safety and Applied Nutrition
Sunstar Guangzhou Lt 2020-01-22 Center for Drug Evaluation and Research | CDER
Cerreta Candy Compan 2020-01-21 Office of Human and Animal Foods ? Division IV West
Smart Toothpicks, LL 2020-01-31 Center for Tobacco Products

Monitor latest FDA approvals

MFG Route Drug Strength NDCs Type Approval Date PI Labels

List of new API DMFs (drug master files) from FDA which is updated quarterly

Company Submit Date Subject
CADILA HEALTHCA 2019-12-31 ENZALUTAMIDE (PROCESS II)
AURORE LIFE SCI 2019-12-31 OXCARBAZEPINE USP
CADILA HEALTHCA 2019-12-31 IMATINIB MESYLATE (PROCESS II)
MSN LIFE SCIENC 2019-12-31 PENICILLAMINE USP
RA CHEM PHARMA 2019-12-24 Hydralazine Hydrochloride USP
RA CHEM PHARMA 2019-12-24 Posaconazole
DR REDDYS LABOR 2019-12-31 EDARAVONE
LUPIN LTD 2019-12-31 LEDIPASVIR
MAITHRI DRUGS P 2019-12-21 DIVALPROEX SODIUM USP
CHANGZHOU PHARM 2019-12-26 RIVAROXABAN
BRIGHTGENE FERM 2019-12-23 ANSAMITOCIN P-3
AURORE LIFE SCI 2019-12-19 DESVENLAFAXINE SUCCINATE
SOLARA ACTIVE P 2019-12-30 SUGAMMADEX SODIUM
GLAND PHARMA LT 2019-12-31 ERYTHROMYCIN LACTOBIONATE
GLAND PHARMA LT 2019-12-26 Cisatracurium Besylate
NANOPHARMACEUTI 2019-12-18 5-Aza-T-dCyd
DR REDDYS LABOR 2019-12-31 ATORVASTATIN CALCIUM TRIHYDRATE [FORM-I] [ATN PROCESS]
ZCL CHEMICALS L 2019-12-31 TICAGRELOR
FORMOSA LABORAT 2019-12-26 RUCAPARIB CAMSYLATE
ZAKLADY FARMACE 2019-12-20 Oxcarbazepine
MSN LABORATORIE 2019-12-31 LUBIPROSTONE
BIOPHORE INDIA 2019-12-28 PIMAVANSERIN TARTRATE
BIOPHORE INDIA 2019-12-31 RAMELTEON
BIOPHORE INDIA 2019-12-27 OBETICHOLIC ACID
LUPIN LTD 2019-12-09 BRIVARACETAM
DR REDDYS LABOR 2019-12-30 SITAGLIPTIN HYDROCHLORIDE (MONOHYDRATE)
SHANGHAI APPLIE 2019-12-23 HUMAN MESENCHYMAL STEM CELL MEDIUM
POLYPEPTIDE LAB 2019-12-06 TERLIPRESSIN ACETATE
SUN PHARMACEUTI 2019-12-31 DROXIDOPA
HYBIO PHARMACEU 2019-12-31 TERIPARATIDE, NON-STERILE BULK DRUG SUBSTANCE
AURORE LIFE SCI 2019-11-30 TOLVAPTAN AMORPHOUS
AURORE LIFE SCI 2019-12-05 TOLVAPTAN
MSN LIFE SCIENC 2019-12-11 " SITAGLIPTIN PHOSPHATE ANHYDROUS"
MYLAN LABORATOR 2019-12-20 EFINACONAZOLE
MYLAN LABORATOR 2019-12-19 PENCICLOVIR
MYLAN LABORATOR 2019-12-05 MESALAMINE USP
NOVITIUM PHARMA 2019-12-17 Methyltestosterone USP
NOVITIUM PHARMA 2019-12-10 DICHLORPHENAMIDE USP
BACHEM AG 2019-12-19 Goserelin Acetate
MICRO LABS LTD 2019-12-21 Brimonidine Tartrate USP
SNJ LABS PVT LT 2019-12-10 IRON SUCROSE CONCENTRATE LIQUID
RA CHEM PHARMA 2019-11-22 VERAPAMIL HYDROCHLORIDE USP
ANQIU LUAN PHAR 2019-12-19 Acetaminophen DC90-10 SD
CIPLA LTD 2019-12-17 SALMETEROL XINAFOATE USP
ALEMBIC PHARMAC 2019-12-11 OBETICHOLIC ACID
JIANGSU HANSOH 2019-12-20 NINTEDANIB ESYLATE, NON-STERILE, BULK DRUG SUBSTANCE
MERCK SANTE SAS 2019-12-13 GLUCOPHAGE XR 500 mg, prolonged release tablets ? Bulk (Reduced Mass)
MSN LIFE SCIENC 2019-11-30 STIRIPENTOL
INDUSTRIALE CHI 2019-12-12 ABIRATERONE ACETATE USP (NP)
RN LABORATORIES 2019-12-11 N-octyl-1-[10-(4-octyliminopyridin-1-yl) decyl] pyridin-4-imine dihydrochloride (Octenidine Dihydrochloride)
AURORE LIFE SCI 2019-11-22 AMLODIPINE BESYLATE USP
MSN LABORATORIE 2019-12-02 TRABECTEDIN
SMS PHARMACEUTI 2019-11-26 LAMIVUDINE USP
MYLAN LABORATOR 2019-11-27 CANAGLIFLOZIN HEMIHYDRATE
GLAND PHARMA LT 2019-12-04 TIGECYCLINE [PROCESS ? II]
FARMHISPANIA S. 2019-12-20 EVEROLIMUS (2.0% BHT)
NEULAND LABORAT 2019-12-31 INDACATEROL MALEATE
INNOPHARMAX INC 2019-12-03 GADOTERATE MEGLUMINE
SMS PHARMACEUTI 2019-11-20 LAMOTRIGINE USP
LIVZON NEW NORT 2019-12-04 PIMAVANSERIN TARTRATE (NON-STERILE, BULK FORM)
AVENTACELL BIOM 2019-12-13 ULTRAGRO - PURE GI
BACHEM AG 2019-11-21 ZP4207
SIEGFRIED EVION 2019-12-03 THREO PHENYL-2-PIPERIDIN-2-YL ACETIC ACID (RITALINIC ACID)
PIRAMAL ENTERPR 2019-12-20 DROXIDOPA
ZHEJIANG GUOBAN 2019-12-07 CIPROFLOXACIN HCL 105 USP
AMRI ITALY SRL 2019-12-06 ROCURONIUM BROMIDE
OLON SPA 2019-12-27 CRISABOROLE
HOVIONE FARMACI 2019-12-20 ACLIDINIUM BROMIDE MICRONIZED
MYLAN LABORATOR 2019-12-03 SODIUM FERRIC GLUCONATE COMPLEX
MYLAN LABORATOR 2019-11-27 PLECANATIDE
ZHEJIANG JIANGB 2019-12-10 LEVETIRACETAM
PCAS 2019-11-27 Estetrol Monohydrate
BIOPHORE INDIA 2019-12-03 NIMODIPINE
BIOPHORE INDIA 2019-12-17 Sincalide
MANKIND PHARMA 2019-11-22 HALOPERIDOL USP
MAPRIMED SA 2019-12-18 NITAZOXANIDE
DISHMAN CARBOGE 2019-12-17 CHOLECALCIFEROL USP
ALEMBIC PHARMAC 2019-11-20 VENETOCLAX
SUN PHARMACEUTI 2019-12-16 ALECTINIB HYDROCHLORIDE
TIANJIN TIANYAO 2019-12-17 Fluticasone propionate USP
EMMENNAR PHARMA 2019-12-11 (S)-(+)-2-AMINOBUTYRAMIDE HYDROCHLORIDE
TIANJIN TIANYAO 2019-12-17 MOMETASONE FUROATE MONOHYDRATE BULK API
NEKTAR THERAPEU 2019-12-13 NKTR-255 DRUG PRODUCT
SUNNY PHARMTECH 2019-12-31 PHYTONADIONE, USP
AURISCO PHARMAC 2019-12-27 16 BETA METHYL EPOXIDE
TEVA PHARMACEUT 2019-12-26 SD-809 DEUTETRABENAZINE
FERMION OY 2019-11-20 NITROFURANTOIN MACROCRYSTAL
CHENGDU SHENGNU 2019-12-13 GANIRELIX ACETATE
CURIUM US LLC 2019-12-31 64CU-DOTATATE
CURIUM US LLC 2019-12-20 COPPER CHLORIDE
SYMED LABS LTD 2019-11-20 DEFERASIROX

Abriged, not to be used by medical professionals, updated daily from the FDA website

Company Drug Reason NDCs Date Lot Quantity

Consolidated Pharma Data Platform, see what is new over the past 30 days.

WIZMED sources is data from the FDA, Dailymed, Medicaid data and other data sources. The data feeds run night, weekly and/or quarterly depending on data source. WIZMED nor any of its agencies, contractors, subcontractors or employees does not make any warranties, expressed or implied, with respect to data contained in these databases or files, and, furthermore, assume no liability for any party's use, or the results of such use, of any part of the database or files.