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

Source: https://www.globalkeysolutions.net/records/483/shilpa-medicare-limited/bcc1fec7-9bb8-4d91-809b-08e9b4874e7d

> 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 Inspections and Investigations
- Summary: Shilpa Medicare Limited received a Form 483 detailing significant deficiencies in their sterile drug product manufacturing. The observations highlight inadequate validation of aseptic and sterilization processes, a deficient visual inspection program, and poor cleaning and maintenance of aseptic processing areas. The firm also failed to thoroughly investigate discrepancies, maintain equipment, and establish scientifically sound laboratory controls and stability programs.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/shilpa-medicare-limited/1533339e-2565-4102-a4c6-10f007e2112a)
- [483 - 2025-11-10](https://www.globalkeysolutions.net/records/483/shilpa-medicare-limited/d193fbef-a05c-4aef-b2ae-b62c96c8860b)
- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/shilpa-medicare-limited/be69043b-06e2-466f-9c9e-69b63f769abd)
- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/shilpa-medicare-limited/6423cdf4-cd19-438d-b4f4-f71cf979403b)
- [WARNING_LETTER - 2020-02-25](https://www.globalkeysolutions.net/records/warning_letter/shilpa-medicare-limited/2e18f8c2-80a9-409d-a285-427792df7cb5)

## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8