FDA 483 - Jagsonpal Pharmaceuticals Ltd - April 03, 2024

Jagsonpal Pharmaceuticals Limited, an API manufacturer in Bhiwadi, India, was inspected and cited for significant deficiencies across its manufacturing and quality control operations. Observations included the unavailability of critical manufacturing and analytical records, failure to verify a USP compendium test method, unrecorded and unjustified deviations in laboratory procedures, and inadequate batch manufacturing records. These issues raise concerns about data integrity, product quality assurance, and overall compliance with good manufacturing practices.