Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Contamination Control and Data Integrity

Granules India received a warning letter from the USFDA in February 2025. This was along

Data Integrity, Cleaning Issues: Granule

USFDA inspected Granules India’s  Finished Dosage and PFI facility (FEI 3004097901) at Gagillapur Village, Hyderabad

USFDA 483 to Torrent: Concerns on Handli

With contributions from: Venkiteswaran.T.K; Satish Reddy; Shashank Sharma; Srinivas Churya; Subrangshu Choudhary, Veena Raj The USFDA Form

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 (FEI 3004561553) was inspected by USFDA in December 2023 by FDA

USFDA 483 to Sun Pharma points to lack o

The USFDA 483 issued to Sun Pharma, Dadra unit in India (FEI 3004561553) published by

FDA Warning letter to Natco over Cleanin

As expected FDA has taken regulatory action and issued a Warning letter to Natco, following

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)

USFDA 483 to Dr.Reddys (DRL) Cites Clean

Dr.Reddys Laboratories (DRL) Medchal, Telengana site was inspected by USFDA (Investigators Saleem A Akhtar &