Warning letters, 483s, Recalls, Import Alerts, Audit observations
Five different facilities of Eugia across India and US were inspected by USFDA between December
Sun Pharma’s Dadra Unit was issued FDA Warning letter in June 2024, following critical observations
Laurus Synthesis was issued an Untitled Letter by USFDA in May 2024, following critical observations
Chinese API Manufacturer Sichuan Deebio Pharmaceuticals was awarded USFDA 483 with six observations citing Data
Centaur India formulation facility at Pune, Maharashtra, India was issued Warning letter by FDA citing
Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate
Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate
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
USFDA Inspection at Cadila Ahmedabad, India in April-May 2019 by Investigators Justin A Boyd, Thomas
