Latest News

0 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

WIZMED searches for the latest public 483s weekly.

MFG Record Type Country Date Link
M Drug, LLC dba Northern Light Pharmacy FMD-145 Letter Maine,USA 2020-04-01
Portland Compounding Pharmacy, LLC dba Lloyd Central Compounding Pharmacy FMD-145 Letter Oregon,USA 2020-04-07
Pentec Health, Inc. FMD-145 Letter Pennsylvania,USA 2020-04-09
Professional Pharmacy Services, Inc. dba Good Day Pharmacy State Referral Letter Colorado,USA 2020-04-14
Professional Pharmacy Services, Inc. dba Good Day Pharmacy FMD-145 Letter Colorado,USA 2020-04-14
Flourish Integrative Pharmacy, LLC dba Flourish Pharmacy FMD-145 Letter Oklahoma,USA 2020-04-15
Wells Pharmacy Network, LLC FMD-145 Letter Tennessee,USA 2020-04-15
Pharmacy Resources, Inc. FMD-145 Letter Colorado,USA 2020-04-25

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

Company Issue Date Office Link
Fusion Health and Vi 2020-05-11 Center for Drug Evaluation and Research | CDER
Kradjian Importing C 2020-05-04 Division of West Coast Imports
Willis Ocean Inc. 2020-04-30 Division of Northeast Imports
Ideal Implant Incorp 2020-05-14 Center for Devices and Radiological Health
Allergan 2020-05-14 Center for Devices and Radiological Health
White Eagle Native H 2020-05-14 Center for Drug Evaluation and Research | CDER
benjaminmcevoy.com 2020-05-14 Center for Drug Evaluation and Research | CDER
Noetic Nutraceutical 2020-05-15 Center for Drug Evaluation and Research | CDER
The Golden Road Krat 2020-05-15 Center for Drug Evaluation and Research | CDER
Center for New Medic 2020-05-11 Center for Food Safety and Applied Nutrition (CFSAN)
Smoked Salmon Unlimi 2020-05-12
Fullest Closet 2020-05-11 Center for Tobacco Products
Health Cabin 2020-05-11 Center for Tobacco Products
New Spirit Naturals 2020-05-07 Division of Human and Animal Food Operations West V
IntegraDose Compound 2020-05-06 Division of Pharmaceutical Quality Operations III
Blaine Labs Inc 2020-05-05 Division of Pharmaceutical Quality Operations IV
Rajshree Internation 2020-05-04 Division of West Coast Imports
SpiceTac 2020-05-19 Center for Drug Evaluation and Research | CDER
Life Unlearned, LLC 2020-05-19 Center for Drug Evaluation and Research | CDER
4nrx.md 2020-05-13 Center for Drug Evaluation and Research | CDER
Apollo Holding LLC 2020-05-21 Center for Drug Evaluation and Research | CDER
North Coast Biologic 2020-05-21 Center for Biologics Evaluation and Research (CBER)
Montgomery Women's M 2020-05-14 Office of Biological Products Operations - Division 1
Maspeth Wholesale Co 2020-05-14 Division of Northeast Imports
D.K. Grocery Inc. DB 2020-05-14 Division of Northeast Imports
88 Special Sweet, In 2020-05-13 Division of West Coast Imports
Samchundang Pharm Co 2020-05-13 Center for Drug Evaluation and Research | CDER
Shenzhen Uptown-Tech 2020-05-12 Center for Tobacco Products
Sioux Smokeless, LLC 2020-05-01 Center for Tobacco Products
Careful Cents, LLC 2020-05-26 Center for Drug Evaluation and Research | CDER
Musthavemom.com 2020-05-26 Center for Drug Evaluation and Research | CDER
Alternativa 2020-05-26 Center for Drug Evaluation and Research | CDER
CBD Gaze 2020-05-26 Center for Drug Evaluation and Research | CDER

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

Company Submit Date Subject
GLENMARK LIFE S 2020-03-30 OXCARBAZEPHIN USP
SRINI PHARMACEU 2020-03-26 HYDROXYCHLOROQUINE SULFATE USP
CKD BIO CORP 2020-03-27 DAPTOMYCIN
DR REDDYS LABOR 2020-03-27 PEMETREXED DISODIUM USP (HEPTAHYDRATE)
BIOPHORE INDIA 2020-03-31 CYCLEN FREEBASE (INTERMEDIATE)
AURORE LIFE SCI 2020-03-20 VALACYCLOVIR HYDROCHLORIDE USP
GLENMARK LIFE S 2020-03-31 SOLRIAMFETOL HYDROCHLORIDE
MSN PHARMACHEM 2020-03-21 LACOSAMIDE
MSN LABORATORIE 2020-03-30 TAFAMIDIS
HIKAL LTD 2020-03-28 SITAGLIPTIN PHOSPHATE ANHYDRATE
METROCHEM API P 2020-03-21 DEXKETOPROFEN TROMETAMOL
AURISCO PHARMAC 2020-03-20 FLUMETHASONE ACID
SYNTHON BV 2020-03-27 LENALIDOMIDE
AMRI ITALY SRL 2020-03-17 OXANDROLONE
LIVZON GROUP FU 2020-03-31 DAPTOMYCIN (PROCESS II)
MSN LIFE SCIENC 2020-03-27 VALBENAZINE TOSYLATE
MAITHRI LABORAT 2020-03-29 TOLTERODINE TARTRATE USP
MSN LIFE SCIENC 2020-03-29 DIROXIMEL FUMATATE
MSN LABORATORIE 2020-03-29 ROLAPITANT HYDROCHLORIDE
MSN LIFE SCIENC 2020-03-26 ZIPRASIDONE MESYLATE TRIHYDRATE
MSN LABORATORIE 2020-03-31 ABEMACICLIB
MSN LABORATORIE 2020-03-31 APALUTAMIDE
MSN LIFE SCIENC 2020-03-28 METOPROLOL SUCCINATE USP
MSN LIFE SCIENC 2020-03-30 METOPROLOL TARTRATE USP
SUN PHARMACEUTI 2020-03-27 CETRORELIX ACETATE
MSN LIFE SCIENC 2020-03-27 FASORACETAM
MSN LIFE SCIENC 2020-03-19 SITAGLIPTIN PHOSPHATE MONOHYDRATE USP
SHANDONG CHENGH 2020-03-30 PRILOCAINE HYDROCHLORIDE
MSN ORGANICS PR 2020-03-14 TICAGRELOR
MSN LABORATORIE 2020-03-31 OLAPARIB
MSN LABORATORIE 2020-03-28 TAFAMIDIS MEGLUMINE
MSN LABORATORIE 2020-03-31 ILOPROST
MSN LABORATORIE 2020-03-14 DEXRAZOXANE
INTAS PHARMACEU 2020-03-23 PAZOPANIB HYDROCHLORIDE
MOREPEN LABORAT 2020-03-18 DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
ASPEN OSS BV 2020-03-17 HEPARIN SODIUM
SHANGHAI WONDER 2020-03-16 DYPHYLLINE
SHANGHAI WONDER 2020-03-16 DULOXETINE HYDROCHLORIDE
INTAS PHARMACEU 2020-03-27 DIROXIMEL FUMARATE
DR REDDYS LABOR 2020-03-12 DASATINIB MONOHYDRATE
JIANGSU HENGRUI 2020-03-31 GADOTERATE MEGLUMINE
BIOPHORE INDIA 2020-03-06 MEXILETINE HYDROCHLORIDE
DR REDDYS LABOR 2020-03-24 APALUTAMIDE
DR REDDYS LABOR 2020-03-31 ROXADUSTAT
DR REDDYS LABOR 2020-03-31 MIDOSTAURIN
DR REDDYS LABOR 2020-03-24 Diluted Everolimus 5%
MSN LABORATORIE 2020-03-11 "EDARAVONE"
UNICHEM LABORAT 2020-03-20 CYCLOBENZAPRINE HYDROCHLORIDE USP
UNICHEM LABORAT 2020-03-26 GUANFACINE HYDROCHLORIDE USP
INNOVARE LABS P 2020-03-28 CLOPIDOGREL BISULFATE USP
ALEMBIC PHARMAC 2020-03-30 ELVITEGRAVIR
ALEMBIC PHARMAC 2020-03-31 LINEZOLID USP (FORM-I)
DR REDDYS LABOR 2020-03-12 FEXOFENADINE HYDROCHLORIDE USP (FORM-I)
TEVA PHARMACEUT 2020-03-11 CYCLOSPORINE ID: 741310
HANGZHOU COBETT 2020-03-10 TFF CASSETTE
MAITHRI DRUGS P 2020-03-06 NITROFURANTOIN ANHYDROUS USP (MACROCRYSTALS)
JOYANG LABORATO 2020-03-03 Tacrolimus
INDENA SPA 2020-03-11 RESINIFERATOXIN
YANGZHOU LIANAO 2020-03-20 STAUROSPORINE
PIRAMAL ENTERPR 2020-03-30 BEXAGLIFLOZIN
ALKALOIDA CHEMI 2020-03-10 PHENOBARBITAL SODIUM,USP
TAIHO PHARMACEU 2020-03-16 TRIFLURIDINE DRUG SUBSTANCE
SAFC BIOSCIENCE 2020-03-17 CELL CULTURE MEDIUM 14366C
CENTURY PHARMAC 2020-03-13 OXYTETRACYCLINE DIHYDRATE USP
CENTURY PHARMAC 2020-03-09 AZITHROMYCIN DIHYDRATE USP
CENTURY PHARMAC 2020-03-12 ERYTHROMYCIN STEARATE USP
CENTURY PHARMAC 2020-03-09 ERYTHROMYCIN ETHYLSUCCINATE USP
POLYMED THERAPE 2020-03-12 ENCEQUIDAR METHANESULFONATE MONOHYDRATE DRUG SUBSTANCE
MANKIND PHARMA 2020-03-31 Ranolazine
HEMMO PHARMACEU 2020-03-19 CETRORELIX
NATCO PHARMA LT 2020-03-03 CARMUSTINE
METROCHEM API P 2020-03-03 SILODOSIN
HONOUR LAB LTD 2020-03-06 DIATRIZOATE SODIUM
NOVITIUM PHARMA 2020-03-12 Betaine Anhydrous
CHENGDA PHARMAC 2020-03-31 ABT76
SHANDONG XINHUA 2020-03-10 ETHYL ICOSAPENTATE 98
LABORATORIUM OF 2020-03-17 HISTAMINE DI-HYDROCHLORIDE
UNICHEM LABORAT 2020-03-17 Hydralazine Hydrochloride USP
NORTH CHINA PHA 2020-03-25 TACROLIMUS USP
SINOPEP-ALLSINO 2020-03-26 FULVESTRANT
CEDARBURG PHARM 2020-03-02 METHYLNALTREXONE BROMIDE

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.