Discussion forum for Pharma Quality events, Regulatory Actions

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

Warning letter / Centaur / July 2023 / C

Centaur India formulation facility at Pune, Maharashtra, India was issued Warning letter by FDA citing

Qvents
September 19, 2023

USFDA 483 / Intas / May 2023 /Manipulati

USFDA483 to Intas cites manipulated visual inspection reports; failure to characterise particles observed in injection

Qvents
July 24, 2023

USFDA Warning letters, 483s, WHO Alerts

Potential contamination of drug products with Diethylene Glycol(DEG), Ethylene Glycol(EG) has severe consequences including fatality

Qvents
May 10, 2023