Latest News

80 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
MSD International Gm Las Piedras US 2020-02-26 Drug Quality Assurance VAI
Abbvie LTD Barceloneta US 2020-02-20 Drug Quality Assurance VAI
Bristol-Myers Squibb Humacao US 2020-02-14 Drug Quality Assurance NAI
Cardinal Health 414, Seattle US 2020-02-25 Drug Quality Assurance VAI
Northwest Cosmetic L Idaho Falls US 2020-02-24 Drug Quality Assurance VAI
ABCO Laboratories, I Fairfield US 2020-03-13 Drug Quality Assurance VAI
Exel Inc. d/b/a DHL Manchester US 2020-03-13 Drug Quality Assurance VAI
SGS Chemical Solutio Harrisburg US 2020-02-06 Drug Quality Assurance NAI
SMS Pharmaceuticals Hyderabad IN 2020-03-05 Drug Quality Assurance NAI
Strides Pharma Scien Bangalore IN 2020-03-05 Drug Quality Assurance NAI
Reactimex S.A. de C. Monterrey MX 2020-03-05 Drug Quality Assurance VAI
Cadila Healthcare Lt Moraiya IN 2020-03-04 Drug Quality Assurance NAI
VKT Pharma Private L Derasam IN 2020-02-28 Drug Quality Assurance VAI
Aurobindo Pharma Lim Menakuru IN 2020-02-28 Drug Quality Assurance VAI
Cyan Labs S.A. de C. Ciudad Apodaca MX 2020-02-28 Drug Quality Assurance VAI
Intas Pharmaceutical Ahmedabad IN 2020-02-28 Drug Quality Assurance VAI
Biocon Limited Bangalore IN 2020-02-26 Drug Quality Assurance VAI
Amneal Pharmaceutica Ahmedabad IN 2020-02-21 Drug Quality Assurance NAI
Quimica y Farmacia S Ramos Arizpe MX 2020-02-21 Drug Quality Assurance NAI
Alkem Laboratories L Baddi, Solan IN 2020-02-21 Drug Quality Assurance VAI
Solara Active Pharma Puducherry IN 2020-02-21 Drug Quality Assurance NAI
Qually Corporacion, Ciudad De Mexico MX 2020-02-19 Drug Quality Assurance VAI
Amneal Pharmaceutica Ahmedabad IN 2020-02-18 Drug Quality Assurance NAI
Evonik Technology an Marl DE 2020-02-18 Drug Quality Assurance NAI
Dr Reddy's Laborator Ranasthalam Mandal, Srikakulam IN 2020-02-14 Drug Quality Assurance NAI
Cadila Pharmaceutica Ahmedabad IN 2020-02-14 Drug Quality Assurance NAI
Lupin Ltd. Aurangabad IN 2020-02-14 Drug Quality Assurance NAI
Pharbil Waltrop Gmbh Waltrop DE 2020-02-14 Drug Quality Assurance VAI
Granules India Limit Medchal-Malkhajgiri District IN 2020-02-14 Drug Quality Assurance VAI
Recipharm Pharmaserv Bangalore IN 2020-02-13 Drug Quality Assurance VAI
Elementis Pharma Gmb Ludwigshafen Am Rhein DE 2020-02-12 Drug Quality Assurance NAI
Services Pharmaceuti Boucherville CA 2020-02-11 Drug Quality Assurance NAI
BioMylz Pvt. Ltd. Bengaluru IN 2020-02-07 Drug Quality Assurance VAI
Sionc Pharmaceutical Visakhapatnam IN 2020-02-07 Drug Quality Assurance VAI
Bakul Aromatics and Raigad IN 2020-02-07 Drug Quality Assurance VAI
TWI Pharmaceuticals, Taoyuan City TW 2020-02-07 Drug Quality Assurance VAI
Mylan Laboratories L Sinnar IN 2020-02-07 Drug Quality Assurance NAI
Unique Pharmaceutica Bharuch IN 2020-02-07 Drug Quality Assurance VAI
USV Private Limited Takula Khed, Dist. Ratnagiri IN 2020-02-07 Drug Quality Assurance NAI
Sun Pharmaceutical I Mohali IN 2020-02-07 Drug Quality Assurance VAI
Ames Goldsmith Corpo Glens Falls US 2020-03-06 Drug Quality Assurance VAI
Callahan Chemical Co Palmyra US 2020-02-12 Drug Quality Assurance NAI
Kashiv BioSciences, Bridgewater US 2020-02-07 Drug Quality Assurance NAI
Isomedix Operations, Northborough US 2020-03-09 Drug Quality Assurance NAI
Genzyme Corporation Northborough US 2020-02-28 Drug Quality Assurance NAI
Charles River Labora Wilmington US 2020-02-11 Drug Quality Assurance VAI
Chattem Plant 1 Chattanooga US 2020-03-13 Drug Quality Assurance VAI
Owen Biosciences Inc Baton Rouge US 2020-02-14 Drug Quality Assurance VAI
Scapa Tapes North Am Knoxville US 2020-02-07 Drug Quality Assurance VAI
Kendrick Laboratorie Madison US 2020-03-10 Drug Quality Assurance VAI
TECHNICHEM CORP Anaheim US 2020-03-18 Drug Quality Assurance VAI
McKenna Labs Inc Fullerton US 2020-03-05 Drug Quality Assurance VAI
Bausch & Lomb Incorp Irvine US 2020-02-28 Drug Quality Assurance VAI
Soaptronic LLC Lake Forest US 2020-02-14 Drug Quality Assurance VAI
Airgas USA LLC Santa Ana US 2020-02-12 Drug Quality Assurance NAI
Grain Processing Cor Muscatine US 2020-02-13 Drug Quality Assurance VAI
S and B Pharma, Inc. Fenton US 2020-02-06 Drug Quality Assurance VAI
LUPIN RESEARCH INC. Coral Springs US 2020-02-26 Drug Quality Assurance VAI
Applied Consumer Ser Hialeah Gardens US 2020-02-21 Drug Quality Assurance VAI
Torrance Company Portage US 2020-02-25 Drug Quality Assurance NAI
TOLMAR, Inc. Windsor US 2020-02-24 Drug Quality Assurance VAI
Avent, Inc. Tucson US 2020-02-21 Drug Quality Assurance VAI
Septodont Inc. Louisville US 2020-02-10 Drug Quality Assurance NAI
Unilever Manufacturi Jonesboro US 2020-03-10 Drug Quality Assurance VAI
Naturich Cosmetique Garland US 2020-03-06 Drug Quality Assurance VAI
Topicare Management, Conroe US 2020-02-13 Drug Quality Assurance NAI
Chemolee Lab Corpora Irving US 2020-02-10 Drug Quality Assurance NAI
Stronghaven, Inc. d Louisville US 2020-02-21 Drug Quality Assurance VAI
Thornton Industries, Morris US 2020-03-04 Drug Quality Assurance VAI
Hospira Inc Lake Forest US 2020-02-27 Drug Quality Assurance NAI
Isomedix Operations Libertyville US 2020-02-07 Drug Quality Assurance NAI
Jubilant Cadista Pha Salisbury US 2020-02-28 Drug Quality Assurance VAI
Nutravail, LLC. Chantilly US 2020-02-06 Drug Quality Assurance VAI
Eminent Services Cor Frederick US 2020-02-06 Drug Quality Assurance NAI
Generics Bidco II LL Charlotte US 2020-03-11 Drug Quality Assurance NAI
Piedmont Hosp Inc Atlanta US 2020-02-18 Drug Quality Assurance VAI
Family Pharmacy of S Statesville US 2020-02-12 Drug Quality Assurance VAI
FMC Corporation FMC Bessemer City US 2020-02-07 Drug Quality Assurance VAI
PTI Royston LLC Royston US 2020-02-06 Drug Quality Assurance VAI
PAI Holdings, LLC. d Greenville US 2020-02-06 Drug Quality Assurance NAI

WIZMED searches for the latest public 483s weekly.

MFG Record Type Country Date Link
Vita Pharmacy, LLC dba Talon Pharmacy of Boerne 483 Texas, USA 2020-02-11
Blount Discount Pharmacy, Inc. 483 Tennessee, USA 2020-02-13
Geneva Woods Pharmacy dba Geneva Woods Professional Infusion Pharmacy State Referral Letter Alaska, USA 2020-02-18
Geneva Woods Pharmacy dba Geneva Woods Professional Infusion Pharmacy FMD-145 Letter Alaska,USA 2020-02-18
Maitland Labs of Central Florida 483 Florida, USA 2020-02-28
Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy 483 California, USA 2020-03-02
Shilpa Medicare Ltd. 483 INDIA 2020-02-25
Dr. Reddy's Laboratories CTO 5 483 INDIA 2020-03-05
Biocon Sdn Bhd 483 Malaysia 2020-02-21
Immunomedics Inc. 483 USA 2020-03-10
Vitalab Pharmacy, Inc. dba Vasco Rx Specialty Pharmacy State Referral Letter Arizona 2020-02-06
Vitalab Pharmacy, Inc. dba Vasco Rx Specialty Pharmacy FMD-145 Letter Arizona 2020-02-06
Geneva Woods Pharmacy, Inc. dba Geneva Woods Pharmacy FMD-145 Letter Alaska 2020-02-06
Geneva Woods Pharmacy, Inc. dba Geneva Woods Pharmacy State Referral Letter Alaska 2020-02-06
A Chem Rx, LLC dba Cortez Drugs 483 Florida 2020-02-07

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

Company Issue Date Office Link
Premiumestore, LLC 2020-03-10 Center for Tobacco Products
Global Tobacco LLC d 2020-03-10 Center for Tobacco Products
W3 Markets LLC d/b/a 2020-03-10 Center for Tobacco Products
United Tobacco Vapor 2020-03-10 Center for Tobacco Products
Whitelightning USA L 2020-03-10 Center for Tobacco Products
Apollo Future Techno 2020-03-10 Center for Tobacco Products
Windlas Healthcare P 2020-03-10 Center for Drug Evaluation and Research | CDER
Invitrx Therapeutics 2020-03-16 Center for Biologics Evaluation and Research (CBER)
Bravo Packing, Inc. 2020-03-16 Division of Human and Animal Food Operations East II
Hangzhou Linkeweier 2020-03-13 Center for Drug Evaluation and Research | CDER
DermaPharm A/S 2020-03-10 Center for Drug Evaluation and Research | CDER
Carahealth 2020-03-26 Center for Drug Evaluation and Research | CDER
Corona-cure.com 2020-03-26 Center for Drug Evaluation and Research | CDER
JRB Enterprise Group 2020-03-30 Center for Drug Evaluation and Research | CDER
Halosense Inc. 2020-03-30 Center for Drug Evaluation and Research | CDER
Bioactive C60/Fuller 2020-03-30 Center for Drug Evaluation and Research | CDER
Pfizer Healthcare In 2020-03-25 Center for Drug Evaluation and Research | CDER
Shung Kee Food Co., 2020-03-20 Office of Human and Animal Food Operations East Division 1
Bulletproof 360 Inc 2020-03-20 Division of Human and Animal Food Operations West VI
Pharmcore Inc. dba H 2020-03-11 Office of Pharmaceutical Quality Operations, Division II
NeuroXPF 2020-03-31 Center for Drug Evaluation and Research | CDER
Health Mastery Syste 2020-04-01 Center for Drug Evaluation and Research | CDER
Homeomart Indibuy 2020-04-01 Center for Drug Evaluation and Research | CDER
Gaia's Whole Healing 2020-04-01 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

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.