FDA 483 - Jagsonpal Pharmaceuticals Ltd - April 03, 2024

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from March 12 to April 3, 2024, Jagsonpal Pharmaceuticals Limited, an API Manufacturer located in Bhiwadi, India, received a Form FDA 483. The inspection revealed several significant observations indicating deviations from Current Good Manufacturing Practices (cGMP).

The main violations centered on the manufacturing of (b)(4) USP, particularly concerning activities conducted at an unregistered contract manufacturing site. Inspectors found a critical lack of essential records, including comprehensive analytical laboratory data, equipment qualification, cleaning validation/verification records, equipment usage logs, process validation, change control documentation, investigation records for out-of-specifications (OOS) or deviations, and maintenance records.

Further observations noted the firm's failure to conduct a verification process for the USP compendium test method used for (b)(4) USP, which compromises the assurance of proper analysis for shipped batches. Deviations from written test procedures and laboratory mechanisms were found to be unrecorded and unjustified, with analyses performed without proper batch identification and unaddressed impurities. Lastly, Batch Manufacturing Records for (b)(4) USP were deemed inadequate, missing critical manufacturing process and equipment details. Jagsonpal Pharmaceuticals Limited is required to respond to these observations by outlining prompt and comprehensive corrective and preventive actions to ensure adherence to regulatory standards.