Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

USFDA 483 to Biocon Points Lapses in Equ

Biocon Visakh (Biocon Biosphere Limited, FEI 30221 25340) was inspected by USFDA investigator  Brandy N

Zydus Jarod Facility Classified OAI

Zydus Jarod facility (FEI 3013712903) is classified OAI by USFDA in July 2024. The USFDA

Dr.Reddy’s Recall Allopurinol Tablets

Dr.Reddys Laboratories (DRL) has initiated recall of one lot of Allopurinol Tablets, USP 300mg in

Sagent recalls Docetaxel Injection for p

Sagent is recalling two lots of Docetaxel injection in US. The recall follows a customer

Chine API Manufacturer Chengdu KeCheng I

The USFDA issued a Warning Letter to the Chinese API manufacturer Chengdu KeCheng Fine Chemicals

Sichuan Deebio – 483, OAI and Warning

Chinese API Manufacturer Sichuan Deebio Pharmaceuticals was awarded USFDA 483 with six observations citing Data

USFDA 483 to Laurus: Lapses in cleaning,

Laurus, Visakh was issued USFDA 483 with five (5) observations following USFDA inspection by investigators

USFDA 483 to Laurus cites deficiency in

Laurus, Visakh (India) was issued USFDA 483 with five (5) observations following USFDA inspection by

USFDA 483 to Laurus: Lapses in investiga

Laurus, Visakh was issued USFDA 483 with five (5) observations following USFDA inspection by investigators

USFDA 483 /Dr.Reddys (DRL) / October 202

Dr.Reddy’s Laboraties (DRL) site was inspected by USFDA (Investigators Saleem A Akhtar & Pratik S