# FDA 483 - Shilpa Medicare Limited - November 21, 2025

Source: https://www.keypedia.com/records/483/shilpa-medicare-limited/23c8233a-d1cf-4df4-b6c2-a4ab47835266

> FDA 483 for Shilpa Medicare Limited on November 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shilpa Medicare Limited
- Inspection Date: 2025-11-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Shilpa Medicare Limited in Polepally, India, revealed critical deficiencies in the manufacturing of sterile drug products. The firm failed to adequately validate aseptic and sterilization processes, maintain proper visual inspection programs, and ensure equipment cleanliness and maintenance. Significant issues were also noted in discrepancy investigations, data integrity, and the scientific soundness of laboratory controls and stability programs.

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## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [Youkeun Kim](https://www.keypedia.com/people/youkeun-kim/94ccfde4-72f7-4df1-9c68-ede73e5e23d0)
- [Drug National Expert](https://www.keypedia.com/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)

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

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