# FDA 483 - Shilpa Medicare Limited - Unknown Date

Source: https://www.keypedia.com/records/483/shilpa-medicare-limited/1533339e-2565-4102-a4c6-10f007e2112a

> FDA 483 for Shilpa Medicare Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Shilpa Medicare Limited
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: The FDA inspection of Shilpa Medicare Limited revealed significant deficiencies across multiple areas, including a failing Quality Unit that inadequately classified complaints and OOS results, and a lack of effective CAPAs. The firm demonstrated poor control over sterile and non-sterile drug product manufacturing, with issues in process validation, aseptic processing, environmental monitoring, and laboratory controls. Additionally, the company failed to maintain proper instrument calibration, ensure data integrity, manage reserve samples correctly, and submit timely Field Alert Reports, indicating systemic quality and compliance breakdowns.

## Related Documents

- [483 - 2025-11-10](https://www.keypedia.com/records/483/shilpa-medicare-limited/d193fbef-a05c-4aef-b2ae-b62c96c8860b)
- [CRL - Unknown Date](https://www.keypedia.com/records/crl/shilpa-medicare-limited/be69043b-06e2-466f-9c9e-69b63f769abd)
- [CRL - Unknown Date](https://www.keypedia.com/records/crl/shilpa-medicare-limited/6423cdf4-cd19-438d-b4f4-f71cf979403b)
- [WARNING_LETTER - 2020-02-25](https://www.keypedia.com/records/warning_letter/shilpa-medicare-limited/2e18f8c2-80a9-409d-a285-427792df7cb5)
- [483 - 2017-11-30](https://www.keypedia.com/records/483/shilpa-medicare-limited/cebe91e8-c966-4b3d-892f-a55312c72fbf)

## Related Officers

- [Miguel A. Martinez](https://www.keypedia.com/people/miguel-a-martinez/62e722b2-30bd-4671-9db9-8f089093e5a5)
- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)

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