Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA Inspection of Pharmathen’s Rodopi facility in Greece (FEI 3009961173) resulted in issuance of Form
Novo Nordisk’s Bloomington plant (FEI 3005949964, Catalent Indiana LLC) is classified OAI by USFDA in
Novo Nordisk owned Catalent Indiana sterile products formulation facility was inspected by USFDA in June
Indoco Remedies’ Goa Plant (FEI 3005124189) received a warning letter from the FDA following critical
In May 2023 several Injectable products manufactured by Indian Contract Manufacturer Astral SteriTech Pvt. Ltd
USFDA 483 / Lupin, Pithampur, India / FEI 3007549629/ Inspection Mar 21 – Mar 29, 2023
