# FDA 483 - SRI Krishna Pharmaceuticals Ltd - Unit I - September 01, 2023

Source: https://www.globalkeysolutions.net/records/483/sri-krishna-pharmaceuticals-ltd-unit-i/6e5e2af0-2250-4586-b754-3b07e8f471ec

> FDA 483 for SRI Krishna Pharmaceuticals Ltd - Unit I on September 01, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SRI Krishna Pharmaceuticals Ltd - Unit I
- Inspection Date: 2023-09-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Sri Krishna Pharmaceuticals Limited - UNIT-I, an API manufacturer in Hyderabad, India, was cited for numerous significant cGMP deficiencies during an FDA inspection. Issues include widespread failures in Quality Unit oversight, inadequate equipment cleaning and validation, deficient out-of-specification and complaint investigations, and an insufficient stability monitoring program. These observations indicate a systemic lack of control over critical manufacturing processes and data integrity.

## Related Documents

- [483 - 2025-04-18](https://www.globalkeysolutions.net/records/483/sri-krishna-pharmaceuticals-ltd-unit-i/acb7723a-121f-4a23-a724-9e6969aa8323)

## Related Officers

- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.globalkeysolutions.net/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)
- [Pratik S. Upadhyay](https://www.globalkeysolutions.net/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)

Company: https://www.globalkeysolutions.net/companies/sri-krishna-pharmaceuticals-ltd-unit-i/a8609781-dc13-4ad6-9bb3-047ead2bf151

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