Cipla Limited – FDA 483, Sep 28, 2018

This FDA Form 483 document details observations made during an inspection, citing deficiencies in batch production records and investigation procedures.

**Observation 1** highlights a deficiency in batch production and control records. The proposed commercial master batch record for (b)(4) tablets, (b)(4) version 01, lacks written instructions for the removal of the (b)(4) bag from In Process Containers (IPCs) and the subsequent pouring of (b)(4) back into the same IPC for docking with compression systems. This indicates a gap in documenting significant manufacturing steps.

**Observation 2** addresses issues with written records of investigations into unexplained discrepancies. Specifically, a change to production instructions was implemented before all corrective actions related to a deviation were completed. Deviation DEV-1006-2017-00073 for (b)(4) tablets, USP (b)(4) ng lot (b)(4), involved AQL non-compliance for minor defects. A remedial action to revise the "Inspection by Attributes for Inprocess Checks of (b)(4) Tablets" form, changing "Minor spots" to "Minor spots (Other than (b)(4) Spots)," was completed and implemented on November 21, 2017. However, this occurred before the approval of Change Request 1006-P-18-00004 (initiated January 10, 201