Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Dr.Reddy’s Recall Allopurinol Tablets

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

Inadequacy of Investigations, Root cause

Laurus Synthesis was issued an Untitled Letter by USFDA in May 2024, following critical observations

Sagent recalls Docetaxel Injection for p

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

Sun Pharma Dadra USFDA 483 cites Lack of

Sun Pharma Dadra unit (FEI 3004561553) was inspected by USFDA in December 2023 by FDA

Chine API Manufacturer Chengdu KeCheng I

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

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