# FDA 483 - Sri Krishna Pharmaceuticals Limited - May 19, 2023

Source: https://www.globalkeysolutions.net/records/483/sri-krishna-pharmaceuticals-limited/69fbf128-0b1e-444d-9894-808870210337

> FDA 483 for Sri Krishna Pharmaceuticals Limited on May 19, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sri Krishna Pharmaceuticals Limited
- Inspection Date: 2023-05-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Sri Krishna Pharmaceuticals Ltd. - Unit 2, an Indian drug manufacturer, was cited for significant deficiencies across its quality system during an FDA inspection. The observations highlight a systemic failure in thoroughly investigating discrepancies, inadequate process controls, poor equipment cleaning, facility maintenance issues, and critical lapses in document control, data integrity, and complaint handling. These issues indicate a severe lack of oversight and adherence to GMP regulations.

## Related Documents

- [483 - 2025-06-27](https://www.globalkeysolutions.net/records/483/sri-krishna-pharmaceuticals-limited/35c8f8b8-c6d7-42db-bc15-1103a9b10ebc)

## Related Officers

- [Arsen Karapetyan](https://www.globalkeysolutions.net/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)
- [Research Specialist II](https://www.globalkeysolutions.net/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.globalkeysolutions.net/companies/sri-krishna-pharmaceuticals-limited/5afbb0e4-2595-4bfc-8ecd-7c0d9deb8b38

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1