Discussion forum for Pharma Quality events, Regulatory Actions

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

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

Accord (Intas) recall Multiple Injection

Accord USA has initiated recall of multiple lots of Atropine Sulfate, USP 8 mg per

Qvents
July 17, 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

Centrient India Warning Letter Flags Def

Warning letter / Centrient India / MARCS-CMS 640196/ 320-23-06/ DECEMBER 07, 2022/ Observation 3 The

Qvents Team
April 18, 2023