Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA 483 Cites Piramal Pharma for Inves

Piramal Pharma’s API unit at Navi Mumbai was issued USFDA Form 483 with six observations

Janssen’s Korea Vaccine Unit USFDA 483

Janssen’s Korean Vaccine unit Janssen Vaccines Corporation received an USFDA 483 for critical cGMP deviations.

FDA Warning Letter to Indoco Remedies Fl

Indoco Remedies’ Goa Plant received a warning letter from the FDA following critical observations during

Sun Pharma Dadra USFDA 483 cites Lack of

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

USFDA 483 to Sun Pharma points to lack o

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

Lupin USFDA 483 cites deficient failure

USFDA 483 to Lupin Pithampur in Mar 2023 (Inspectors Eileen A Liu, Yvins Dezan) cites

USFDA 483 to Cipla cites deficiencies in

USFDA inspection of Cipla Pithampur site ( FEI 3008581988) by Inspectors Saleem A Akhtar & 

USFDA 483 Flags Dupont for Lapses in Avi

USFDA issues Warning letter to DuPont Nutrition USA Inc., Newark, Delaware facility (FEI 3013947845) for