# FDA 483 - Sri Krishna Pharmaceuticals Limited - Unit IV - August 04, 2023

Source: https://www.keypedia.com/records/483/sri-krishna-pharmaceuticals-limited-unit-iv/566b8d68-3168-49cd-bb9e-4e61526c5d23

> FDA 483 for Sri Krishna Pharmaceuticals Limited - Unit IV on August 04, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sri Krishna Pharmaceuticals Limited - Unit IV
- Inspection Date: 2023-08-04
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Sri Krishna Pharmaceutical LTD, an API manufacturer in Telangana, India, revealed significant deficiencies across its quality system. The firm was cited for inadequate investigations into out-of-specification results and data integrity issues, as well as failures in laboratory controls and equipment design. Further observations included insufficient cleaning validation and a deficient stability monitoring program, indicating a systemic lack of robust quality oversight and control over critical manufacturing and testing processes.

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## Related Officers

- [Vaishali J. Patel](https://www.keypedia.com/people/vaishali-j-patel/3d515b84-e0fd-4f96-914c-f7f09e2de307)
- [Drug National Expert](https://www.keypedia.com/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)

Company: https://www.keypedia.com/companies/sri-krishna-pharmaceuticals-limited-unit-iv/fd405e8b-b747-4adb-bbb5-da63c0cfa56b

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