Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Zydus Jarod Facility Classified OAI

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

Warning letter Sun Pharma Dadra Unit: In

Sun Pharma’s Dadra Unit was issued FDA Warning letter in June 2024, following critical observations

Sun Pharma Dadra USFDA 483 cites Lack of

Sun Pharma Dadra unit was inspected by USFDA in December 2023 by FDA investigator Pratik

Cipla Patalganga USFDA 483 highlights Cl

USFDA inspection of Cipla, Patalganga site manufacturing APIs and Tablets resulted in USFDA 483 with

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

USFDA 483 to Dr.Reddys (DRL) : Cleaning

The DRL site was inspected by USFDA (Investigators Saleem A Akhtar & Pratik S Upadhyay)