Jagsonpal Pharmaceuticals Under Fire: USFDA Raises Alarm

Jagsonpal Pharmaceuticals has received a warning from the USFDA for significant manufacturing lapses at its API plant in Rajasthan. The US regulator cites deviations from Good Manufacturing Practice, inadequate quality systems, and restricted inspection access. Compliance is required for future approvals and operations.

The US Food and Drug Administration (USFDA) has issued a warning to Jagsonpal Pharmaceuticals for significant manufacturing deficiencies at its active pharmaceutical ingredient (API) plant in Rajasthan.

During inspections conducted in March and April 2024, the USFDA identified deviations from Current Good Manufacturing Practice (CGMP), leading to allegations of adulterated products. It cited the company's inadequate quality systems and difficulty in accessing requested documents during inspections.

The regulator has mandated that Jagsonpal Pharmaceuticals rectify these issues within a stipulated timeframe and warned that non-compliance could result in withheld approvals for new products until the issues are resolved.