Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Hetero Warehouse Flagged for Serious Lap

FDA conducted an inspection at the Hetero Labs Ltd, Warehouse at Nakkapally Village, Vishakapatnam, Andra

Malta Medicines Authority Maintains cGMP

Pune based Akriti Pharmaceuticals Private Limited’s EUGMP Certificate remains suspended as the facility remains in

Hetero USFDA Form 483: Unregistered Test

The USFDA inspection of Hetero Labs Ltd, Unit-IX (FEI: 3009093782), Narasapuram, India, conducted in September

Janssen Vaccine Unit Warning Letter Flag

Janssen Vaccines Corp., a Johnson & Johnson company operating in Korea, was issued an FDA

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