FDA 483 - Sun Pharmaceuticals Industries Ltd. - April 13, 2017

This FDA Form 483 details multiple observations from an inspection. Laboratory records were incomplete, with discarded graphs and data printouts for Atomic Absorption Spectroscopy (AAS) content tests not included, and an uncontrolled Excel spreadsheet used for content uniformity calculations not retained in data packets. Raw data for working reference standard preparation, including weights and amounts, was missing.

Batch production records were inaccurate, evidenced by discarded labels for raw material quantity, stock stickers, and issue coupons found in a trash cart, along with unaccounted-for broken tablets. The Quality Control (QC) unit lacked authority over production records, as blank and pre-printed logbooks and issuance stamps were retained by the production department, without QC oversight for issuance and reconciliation.

Drug products were not quarantined before release; five in-process intermediate products past their hold-time expiry were commingled with acceptable products without segregation. Investigations into discrepancies or out-of-specification (OOS) results lacked conclusions and follow-up, with no Root Cause Analysis or Corrective and Preventive Actions (CAPA) initiated for several lab events.

Control procedures for manufacturing processes were inadequate, as evidenced by numerous customer complaints since 2015 regarding overfill and underfill tablets. The existing check weigher in the packaging line was not sensitive enough to detect these issues. Electronic equipment routine checks were not performed according to a written program, with computer software errors (e.g., audit trail errors, instrument communication errors, blank run