# FDA 483 - Intas Pharmaceuticals Limited - May 12, 2023

Source: https://www.keypedia.com/records/483/intas-pharmaceuticals-limited/439bcecd-27da-49d0-b32b-ce7d8d990792

> FDA 483 for Intas Pharmaceuticals Limited on May 12, 2023. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intas Pharmaceuticals Limited
- Inspection Date: 2023-05-12
- Product Type: Tobacco
- Summary: This FDA Form 483 document details multiple observations from an inspection, indicating significant deficiencies in the facility's quality control and manufacturing processes.

**Key Observations:**

*   **Batch Production and Control Records:** Incomplete information in batch records and identical visual inspection records for multiple operators were noted.
*   **Process Controls:** Inadequate controls for tablet compression and a failure to thoroughly review unexplained discrepancies were identified.
*   **Written Procedures:** The firm lacked adequate written procedures for production and process controls to ensure drug product identity, strength, purity, and quality.
*   **Aseptic Processing:** Deficiencies included inadequate validation of aseptic and sterilization processes, insufficient cleaning/disinfection systems, and inadequate environmental monitoring in aseptic areas.
*   **Computer Systems:** Controls over computer systems were insufficient to ensure changes to master records were made only by authorized personnel.
*   **Equipment Maintenance:** Routine checking of automatic, mechanical, and electronic equipment was not performed per a written program. Equipment and utensils were not maintained at appropriate intervals, and equipment design was not appropriate for its intended use.
*   **Quality Control Unit:** Responsibilities and procedures of the quality control unit were not fully followed.
*   **Annual Quality Standards Review:** Procedures for annual quality standards evaluation were deficient, lacking review of a representative number of approved and rejected batches.
*   **Microbiological Contamination:** Procedures to prevent objectionable microorganisms in non-sterile drug products were inadequate.
*

## Related Documents

- [483 - 2022-12-02](https://www.keypedia.com/records/483/intas-pharmaceuticals-limited/aaef987c-6382-4641-8d0e-9fc48ace87ba)
- [WARNING_LETTER - 2025-09-17](https://www.keypedia.com/records/warning_letter/intas-pharmaceuticals-limited/5823afb5-cd04-4920-9a5a-ce851b44651c)
- [483 - 2018-06-08](https://www.keypedia.com/records/483/intas-pharmaceuticals-limited/6c433282-acc9-4639-89b9-e51ca154262e)
- [483 - 2019-08-02](https://www.keypedia.com/records/483/intas-pharmaceuticals-limited/d8b8b922-c242-4064-89d5-38ff992edec5)
- [483 - 2018-12-14](https://www.keypedia.com/records/483/intas-pharmaceuticals-limited/d7d4f9f0-3246-4bd4-b45d-b1149c0a717e)

## Related Officers

- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [Rita Kabaso](https://www.keypedia.com/people/rita-kabaso/a8383d6d-b945-4edc-97a4-90944574835d)

Company: https://www.keypedia.com/companies/intas-pharmaceuticals-limited/0db00702-d7f6-4a8b-87d1-1b32ac236cc8