# FDA 483 - Alkem Laboratories Limited - March 27, 2024

Source: https://www.globalkeysolutions.net/records/483/alkem-laboratories-limited/bce26e83-bff1-42f6-8658-aec8a2e99fce

> FDA 483 for Alkem Laboratories Limited on March 27, 2024. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alkem Laboratories Limited
- Inspection Date: 2024-03-27
- Product Type: Tobacco
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: This FDA Form 483 details numerous observations from an inspection, indicating significant deficiencies in the facility's quality system and manufacturing operations.

Key issues include:
*   **Inadequate Investigations:** Failure to thoroughly review unexplained discrepancies, batch failures, equipment breakdowns, and recurring deviations. A complaint regarding mixed tablets (12 tablets of Tabs mg in a mg bottle) was concluded without effective recurrence prevention. Manufacturing alarms were not investigated, and their product impact was not assessed.
*   **Quality Unit and Procedures:** Responsibilities and procedures for the quality control unit are not written or fully followed. Change controls are not managed within specified timeframes.
*   **Training Deficiencies:** Employees lack training in their specific operations and GMP procedures.
*   **Computerized System Validation & Data Integrity:** Failure to adequately perform GxP and impact assessments for the Q-Sutra system (data acquisition for in-process testing). The firm performing Q-Sutra validation was not qualified or on the approved service provider list. Electronic data backup failures (including HITSRV-TEST) were not investigated. Controls for computer-acquired data and systems are insufficient, lacking assurance that changes and access are by authorized personnel. HMI alarms and audit trails for manufacturing/packaging are not backed up and are automatically erased. HMI data for a submitted exhibit batch (mg) was not backed up. PQ scripts were executed without protocol instructions.
*   **Facility & Equipment Maintenance/Cleaning:** Buildings

## Related Documents

- [483 - 2017-03-10](https://www.globalkeysolutions.net/records/483/alkem-laboratories-limited/6a42939b-9ba1-4e07-afb4-d872b6502c48)
- [483 - 2020-02-21](https://www.globalkeysolutions.net/records/483/alkem-laboratories-limited/d071b888-452f-4a4b-ad30-6233268ad64d)

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)
- [Yvins Dezan](https://www.globalkeysolutions.net/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)

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-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6