FDA Inspection Reveals GMP Violations at Medgel Facility

The U.S. Food and Drug Administration (FDA) conducted a Good Manufacturing Practice (GMP) inspection of Medgel Private Limited's facility in Pithampur, India, from January 23 to 27, 2023. Contrary to the company's claims, the inspection revealed significant violations of Current Good Manufacturing Practice regulations for finished pharmaceuticals. The FDA issued a Form 483 and subsequently a warning letter dated July 20, 2023, citing inadequate investigations of out-of-specification results, humidity excursions, and data integrity issues. The company failed to properly test components for contaminants like diethylene glycol and ethylene glycol. Medgel must address these violations to avoid potential refusal of admission for their products into the United States.

 

Source: FDA Letter