Warning letters, 483s, Recalls, Import Alerts, Audit observations
Laurus Synthesis was issued an Untitled Letter by USFDA in May 2024, following critical observations
The USFDA issued a Warning Letter to the Chinese API manufacturer Chengdu KeCheng Fine Chemicals
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
Aurobindo Unit 1 (FEI 3004021253) was inspected by USFDA investigator Rita K Kabaso from August
