FDA 483 - NATCO Pharma Limited - January 24, 2017

This FDA Form 483 document details observations from an inspection, highlighting deficiencies in the facility's quality control unit, stability testing program, laboratory controls, and field alert reporting.

**Quality Control Unit Deficiencies:** * **Inadequate Complaint Investigations:** Complaint N/IV/MC/15/016 (lack of effectiveness of (b)(4) mg capsules) lacked assay of returned or retention samples. Complaint N/IV/MC/15/009 (lack of effectiveness of (b)(4) mg tablets) was unsubstantiated due to unavailable lot number, with no documented attempts to obtain the sample as per SOP IVQA/001-06. * **Untimely Incident Investigations:** Stability sample incidents were not closed within the (b)(4) working days required by SOP SQA/01-02. * **Failure to Initiate CAPAs:** No CAPAs were initiated for repeated incidents of 227 stability samples tested outside their timeframe, market complaint N/IV/MC/16/027 (incorrect barcode labels), or laboratory investigations N/V/005/15/006 and N/V/005/15/035 (dirty septa/vials). * **Untimely Complaint Investigations:** Complaint N/IV/MC/15/030 was not finalized within the (b)(