FDA 483 - Jubilant Generics Limited - August 01, 2022

The FDA Form 483 details multiple violations at a pharmaceutical manufacturing facility. A primary concern is the failure to thoroughly review unexplained discrepancies and out-of-specification results for distributed batches. For instance, an aborted dissolution analysis for USP mg Batch No’s: due to improper peak shape was retested, but the initial system suitability criteria were not fully considered, and retest samples showed unknown peaks not present in the original method validation. At least of these tablets were shipped to US customers.

The Quality Control Department only monitors temperature, lacking assurance for other critical parameters. There's a consistent failure to initiate investigations for equipment failures, including twenty-five instances on UV-Visible Spectrometer equipment (ID #QC/UVS/003 and QC/UVS/004) between February 2019 and June 2022, impacting numerous distributed products like Tabs and Tabs USP. The facility lacks a proper procedure for handling laboratory incidents, with many Analytical Interruption Reports (AIRs) remaining open for extended periods.

Procedures for handling extraneous peaks in chromatographic analysis were not followed, with extraneous peaks observed in dissolution tests for USP mg Batch No’s: and distributed to the US. Documentation deficiencies include not recording the number of media plates in incubators during growth promotion testing and failing to document reasons for stoppages in batch manufacturing and packaging records, hindering complaint investigations for issues like broken tablets and short-counts.