Warning letters, 483s, Recalls, Import Alerts, Audit observations
The USFDA issued a Warning letter to Hikal’s API facility in Jigani, Bangalore, India. The
In September 2025, the USFDA classified Sun Pharmaceutical Industries Ltd.’s Halol facility as OAI (Official
The USFDA issued a Warning letter to Amneal Pharmaceuticals following critical deviations observed during an
Novo Nordisk owned Catalent Indiana sterile products formulation facility was inspected by USFDA in June
The U.S. FDA issued a warning letter to International Laboratories Corp. (FEI 3006403166) following CGMP
Piramal Pharma’s API unit at Navi Mumbai (FEI 3008763768) was issued USFDA Form 483 with
Indoco Remedies’ Goa Plant (FEI 3005124189) received a warning letter from the FDA following critical
Authored by: Venkiteswaran.T.K, Subrangshu Chourdhary, Srinivas Churya Jubilant Generics Roorkee facility was inspected in January
Laurus Synthesis was issued an Untitled Letter by USFDA in May 2024, following critical observations
As expected FDA has taken regulatory action and issued a Warning letter to Natco, following
