# FDA 483 - SHILPA MEDICARE LIMITED - May 29, 2026

Source: https://www.keypedia.com/records/483/shilpa-medicare-limited/de1fa7e8-f634-4249-9486-7303dfa35287

> FDA 483 for SHILPA MEDICARE LIMITED on May 29, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SHILPA MEDICARE LIMITED
- Inspection Date: 2026-05-29
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Shilpa Medicare Limited in Bengaluru, India, a drug manufacturer, was cited for significant deficiencies across its quality systems, including inadequate process validation and failure to thoroughly investigate discrepancies. The firm also lacked complete production records, appropriate controls over computer systems, and proper equipment hold time studies.

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Company: https://www.keypedia.com/companies/shilpa-medicare-limited/6cfbc869-e7fb-44ec-b0c6-00d327399fb9

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3