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# FDA Cites Shilpa India Drug Facility on GMPs
- URL: https://www.fdaweb.com/fda-cites-shilpa-india-drug-facility-on-gmps/
- Published: 2020-04-03T12:00:00.000Z
- Updated: 2026-09-14T16:09:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146495

FDA has posted a [15-item FDA 483](https://www.fda.gov/media/136642/download?ref=fdaweb.com) issued 2/25 to Shilpa Medicare following an inspection of the firm’s Telangana, India drug manufacturing facility. The February inspection cited the company over its quality unit. For example, the unit failed to ensure that all production and laboratory control operations follow GMP requirements, the 483 says. It notes that no corrective and preventative actions were implemented to decrease reoccurrence of complaints related to coring/fragmentation that were observed in drug vials. Additionally, the company failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.