# FDA 483 - Alkem Laboratories Limited - March 10, 2017

Source: https://www.globalkeysolutions.net/records/483/alkem-laboratories-limited/6a42939b-9ba1-4e07-afb4-d872b6502c48

> FDA 483 for Alkem Laboratories Limited on March 10, 2017. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alkem Laboratories Limited
- Inspection Date: 2017-03-10
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: 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

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## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)
- [Investigator](https://www.globalkeysolutions.net/people/e-moore/0d2411c5-b9e3-4358-9dab-0a5f253a157a)

Company: https://www.globalkeysolutions.net/companies/alkem-laboratories-limited/308e3070-8ca9-4084-a117-315b7e3f8ba8

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0