Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA issues Warning letter to Intas; Ci

USFDA issued a Warning letter to Intas, Matoda, Ahmedabad facility (FEI 3003157498) on 21 November

Qvents
November 30, 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

Intas FDA 483 cites Manipulation of reco

FDA published the USFDA483 issued to Intas site (FEI 3003157498) in Ahmedabad, India after inspection

Qvents
July 12, 2023