FDA 483 - Alkem Laboratories Limited - March 10, 2017

This FDA Form 483 document outlines observations made during an inspection, focusing on deficiencies in the facility's quality control and manufacturing processes.

**Key Observations:**

* **Stability Testing Program Non-Compliance:** The facility failed to adhere to its written stability testing program, specifically procedure Stability Management QC/063/07. Over 1,000 individual drug product samples were not tested within established timeframes. * Deviation B/D/15/014 (opened November 13, 2015) and CAPA B/CAPA/15/122 (opened December 15, 2015) were initiated to address over 250 samples past due, with a target completion date of December 31, 2015, which was not documented as met. * Deviation B/D/15/015 (opened December 18, 2015) addressed an increase to over 500 samples past due, with a target completion date of February 25, 2016, also not documented as met. * **Incomplete Master Production and Control Records:** Master production and control records lack complete manufacturing and control instructions and special notations. * Procedure QC/082, Operation, Cleaning and Calibration of (Revision 07), does not include instructions for