Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
The USFDA Warning letter to K. C. Pharmaceuticals issued in August 2023, following inspection at
Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate
