Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Centaur Warning letter : Data Integrity,

Centaur Pharmaceuticals, India issued Warning letter by USFDA. The Warning letter dated 5 June 2023

IPCA USFDA 483: Poor Laboratory controls

IPCA Dhar facility was inspected by USFDA in June 2023. The site (FEI 3007574780) was

Eleven observations in USFDA 483 to IPCA

IPCA Ratlam (India) was issued USFDA 483 with 11 observations after inspection in June 2023

FDA Warning letter to Zydus: Previous Re

USFDA Inspection at Cadila Ahmedabad, India in April-May 2019 by Investigators Justin A Boyd, Thomas

Cross Contamination Concerns: FDA Warnin

In September 2022, USFDA issued a Warning letter to Lupin API facility at Tarapur, India

Strides recall Prednisolone tablets for

Strides in July 2022 recalled from US market 1032 bottles of Prednisolone USP 20mg tablets for