# FDA 483 - SATYADEEPTHA PHARMACEUTICALS LIMITED - January 11, 2018

Source: https://www.globalkeysolutions.net/records/483/satyadeeptha-pharmaceuticals-limited/8dd60787-311c-41dc-8463-63ab6f0069fd

> FDA 483 for SATYADEEPTHA PHARMACEUTICALS LIMITED on January 11, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SATYADEEPTHA PHARMACEUTICALS LIMITED
- Inspection Date: 2018-01-11
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Satya Deeptha Pharmaceuticals Limited in Humnabad, India, revealed numerous deficiencies across its manufacturing and quality systems. The firm failed to maintain adequate batch production and control records, properly validate processes and test methods, and ensure the integrity of electronic laboratory data. Significant issues were also noted in supplier qualification, equipment cleaning validation, and the thoroughness of deviation investigations, indicating a broad lack of adherence to cGMP regulations.

## Related Officers

- [Cheryl A. Clausen](https://www.globalkeysolutions.net/people/cheryl-a-clausen/2306b2bc-8f01-4f77-ba2d-1a3186d6f6fc)

Company: https://www.globalkeysolutions.net/companies/satyadeeptha-pharmaceuticals-limited/87694160-6ebd-45b5-b9ae-42dda1e5f4ce

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9