Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA 483 to Laurus: Lapses in cleaning,

Laurus, Visakh was issued USFDA 483 with five (5) observations following USFDA inspection by investigators

Venksin
June 16, 2025

Warning letter / Medgel / July 2023 /Lap

Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate

Qvents
August 23, 2023

Warning letter / Centaur / July 2023 / F

The Warning letter cite Failure of Quality unit in ensuring cGMP compliance, Inadequate control over

Qvents
August 7, 2023

USFDA 483 / UCB, Belgium / FEI 300390935

USFDA 483 to UCB Belgium cites fundamental gaps in document control  – uncontrolled forms for

Qvents
June 3, 2023