Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

FDA Issues Repeat Warning Letter to Thai

The U.S. FDA issued a warning letter to International Laboratories Corp. (FEI 3006403166) following CGMP

Facility Registration Violations, Refusa

Indian API manufacturer Jagsonpal Pharmaceuticals was issued a Warning Letter by the US FDA in

Eudra GMDP lists Everest Organics and Ak

Everest Organics Ltd (Telangana, India) was issued a GMP Non-Compliance Report with recommendation to suspend

USFDA 483 / UCB Farchim SA/ June 2023 /

USFDA 483 / UCB Farchim SA/ June 2023 / Gaps in Data Integrity program, lack

Four Indian Pharma sites issued Warning

Related Links Warning letter Intas Warning letter Centaur Warning letter Medgel Warning letter Baxter Intas

Intas FDA 483 cites Manipulation of reco

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

USFDA 483 / IPCA / June 2023 /Failure of

USFDA Inspected IPCA (Ratlam, India) site in June 2023, Inspectors – Rajiv R Srivastava, Salim

Eleven observations in USFDA 483 to IPCA

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