Warning letters, 483s, Recalls, Import Alerts, Audit observations
Laurus, Visakh was issued USFDA 483 with five (5) observations following USFDA inspection by investigators
Natco Pharma (india) Kothur facility was inspected by USFDA (Investigators Pratik S. Upadhyay and Saleem
Qvent post discusses the Regulatory guidances and Requirements for Electronic data controls and review, Data
Spectrum Laboratories Inc, New Jersey, USA (FEI 2246824) was inspected by FDA investigators Sayyem H
Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate
The Warning letter cite Failure of Quality unit in ensuring cGMP compliance, Inadequate control over
Intas facility at Matoda, Sanand in India (FEIÂ 3004011473) was inspected by FDA investigators Jose E
Centaur Pharmaceuticals, India issued Warning letter by USFDA. The Warning letter dated 5 June 2023
USFDA 483 to UCB Belgium cites fundamental gaps in document control – uncontrolled forms for
USFDA Inspection of Intas, Matoda, Sanand facility in India (FEIÂ 3004011473); from 22 November 2022 to
