# FDA 483 - SMS Pharmaceuticals Limited - March 21, 2025

Source: https://www.globalkeysolutions.net/records/483/sms-pharmaceuticals-limited/c7467f98-2056-4d22-a7da-beb60f631ee0

> FDA 483 for SMS Pharmaceuticals Limited on March 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SMS Pharmaceuticals Limited
- Inspection Date: 2025-03-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of SMS Pharmaceuticals Limited, an API Non-Sterile Drug Substance Manufacturer in Bachupally, India, identified a significant deficiency related to employee training. The firm failed to ensure that Quality Control laboratory reviewers were adequately trained and qualified to review laboratory data for drug product release, as evidenced by specific instances involving assay and residual solvents testing.

## Related Officers

- [Ankur C. Patel](https://www.globalkeysolutions.net/people/ankur-c-patel/602c7d14-2c48-4929-a07b-6e4c235d7f13)

Company: https://www.globalkeysolutions.net/companies/sms-pharmaceuticals-limited/e291cac6-1ec4-4f91-a391-b1dca70f98ab

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