# FDA 483 - Sri Krishna Pharmaceuticals Limited - June 27, 2025

Source: https://www.keypedia.com/records/483/sri-krishna-pharmaceuticals-limited/35c8f8b8-c6d7-42db-bc15-1103a9b10ebc

> FDA 483 for Sri Krishna Pharmaceuticals Limited on June 27, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sri Krishna Pharmaceuticals Limited
- Inspection Date: 2025-06-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: The FDA inspection of Sri Krishna Pharmaceuticals Limited in Hyderabad, India, uncovered significant deficiencies across quality control, process validation, and data integrity. The firm failed to reject contaminated components, concealed critical documents, and demonstrated systemic failures in investigating Out-of-Specification and Out-of-Trend results. These issues highlight a pervasive lack of adequate procedures and oversight, raising concerns about drug product quality and safety.

## Related Documents

- [483 - 2023-05-19](https://www.keypedia.com/records/483/sri-krishna-pharmaceuticals-limited/69fbf128-0b1e-444d-9894-808870210337)

## Related Officers

- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)
- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8