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# Shilpa Medicare FDA-483 Released
- URL: https://www.fdaweb.com/shilpa-medicare-fda-483-released/
- Published: 2018-01-30T12:00:00.000Z
- Updated: 2026-09-14T23:18:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140635

FDA has released the FDA-483 issued following a 1/16-1/19 inspection at Shilpa Medicare Limited, Raichur, Karnataka, India. Observations in the [form](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM594419.pdf?ref=fdaweb.com) were: 

- equipment and utensils are not cleaned and maintained to prevent contamination that would alter the safety, identity, strength, quality, or purity of the intermediates and API manufactured;
- the firm’s environmental monitoring sampling plan is not clearly defined and does not represent worst-case activities and conditions; and
- extractable and leachable studies on a redacted product have not been completed.