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# Indoco Remedies FDA-483 Released
- URL: https://www.fdaweb.com/indoco-remedies-fda-483-released/
- Published: 2025-02-26T12:00:00.000Z
- Updated: 2026-09-14T14:54:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158724

FDA has released the form FDA-483 issued following a 7/16-7/26/2024 inspection at the Indoco Remedies sterile and non-sterile drug manufacturing facility in Vasco Da Gama, Goa, India. The seven inspection observations [were](https://www.fda.gov/media/185524/download?ref=fdaweb.com):

- procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed;
- procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process;
- failure to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit;
- failure to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- failure to maintain in a good state of repair buildings used in the manufacturing, processing, packing, and holding of a drug product;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions; and
- determinations of conformance to appropriate written specifications for acceptance are deficient for in-process materials.