FDA 483 - Alembic Pharmaceuticals Limited - March 25, 2016

During an FDA inspection, several deficiencies were noted regarding quality control, documentation, and contamination prevention.

The quality control unit's procedures were not fully followed, specifically concerning a change to blister packaging machines. A piece of material prepared on-site was introduced to prevent vibration and pill ejection, but this change was not done according to established change control procedures, lacking review, evaluation, and approval by quality assurance. This modification's impact on product quality and potential for contamination is unclear.

Production and process control procedures were not documented contemporaneously. An operator initialed a "Challenge Test" as completed on a batch packaging record, but the test was still in progress on the blister pack line.

Procedures to prevent objectionable microorganisms in non-sterile drug products were inadequate. Air bubbles were observed during microbiological enumeration of samples, and the test procedure (APL/RT0122) lacked sufficient detail to prevent this. The environmental monitoring and swab sampling procedure (ALP/QC/SOP098) failed to include the use of specific media for yeast and mold testing in cleaning validation. A leak was observed from a pipe connecting a water storage tank, with no controls to prevent potential ingress of microorganisms.

Finally, deviation investigation #ALP/QA/DC6020 failed to thoroughly review an unexplained discrepancy. It did not assess other drug products potentially affected by a breach involving a damaged gasket and traveling material, failing to assure no product impact on prior batches.