Warning letters, 483s, Recalls, Import Alerts, Audit observations
Following the USFDA 483 issued in April 2024 and the OAI classification in July 2024,
The USFDA issued a Warning Letter to the Chinese API manufacturer Chengdu KeCheng Fine Chemicals
As expected FDA has taken regulatory action and issued a Warning letter to Natco, following
USFDA Warning letter to Australian API manufacturer cites basic laboratory compliance issues – Inadequate OOS
Chinese API Manufacturer Sichuan Deebio Pharmaceuticals was awarded USFDA 483 with six observations citing Data
FDA issued a Warning letter to Amman Pharmaceuticals following inspection at the facility (FEI 3013501887)
USFDA Inspectors Anders W. Evenson and Arsen Karapetyan had inspected the Sichuan Deebio facility (FEI
The Warning letter (dated November 17, 2023) follows the FDA inspection at Cipla’s Pithampur, Indore
Cipla in a statement informed that its Pithampur, Indore facility is issued an USFDA Warning
Nectar Lifesciences was issued an Untitled letter (UL) by USFDA in Sep 23 citing deficiencies
