# FDA 483 - Shilpa Medicare Limited - November 09, 2023

Source: https://www.globalkeysolutions.net/records/483/shilpa-medicare-limited/9019d81e-706a-4c7c-9ff6-ed3f9ed86354

> FDA 483 for Shilpa Medicare Limited on November 09, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shilpa Medicare Limited
- Inspection Date: 2023-11-09
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Shilpa Medicare Limited, a drug product manufacturer in Pollenpally, Telangana, was cited for significant deficiencies across its quality control, manufacturing, and laboratory operations. Observations included inadequate component testing, failures in OOS investigations, deficient aseptic processing and cleaning, incomplete process validation, and poor data integrity practices. These issues indicate a systemic lack of adherence to cGMP regulations, posing a risk to drug product quality and sterility.

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- [WARNING_LETTER - 2020-02-25](https://www.globalkeysolutions.net/records/warning_letter/shilpa-medicare-limited/2e18f8c2-80a9-409d-a285-427792df7cb5)

## Related Officers

- [Eileen A. Liu](https://www.globalkeysolutions.net/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)

Company: https://www.globalkeysolutions.net/companies/shilpa-medicare-limited/9184777f-89bb-4a33-bcb2-4cc2aa4eb655

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