Discussion forum for Pharma Quality events, Regulatory Actions

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

Natco Pharma USFDA 483 Flags Deficiencie

Natco Pharma’s sterile products manufacturing facility at Rangareddy, Telengana (FEI 3004540906) was inspected by USFDA

Venksin
August 2, 2025

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

Aarti Drugs USFDA 483 Flags Unique Chall

Aarti Drugs API facility in Tarapur, India was inspected by USFDA investigators Rajeev R. Srivastava

Venksin
June 16, 2025

USFDA 483 to Laurus: Lapses in investiga

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

Venksin
March 27, 2025