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# Alembic Pharmaceuticals FDA-483 Out
- URL: https://www.fdaweb.com/alembic-pharmaceuticals-fda-483-out/
- Published: 2025-11-05T12:00:00.000Z
- Updated: 2026-09-14T15:25:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160167

FDA has released the form FDA-483 issued following a 5/26-5/31 inspection at the Alembic Pharmaceuticals active pharmaceutical ingredient manufacturing facility in Tal. Halol, Gujarat, India. The four inspection observations were:

- failure to conduct timely laboratory investigations or to thoroughly determine the root cause;
- failure of laboratory control to include establishment of scientifically sound and appropriate test procedures and specifications designed to assure quality of drug substances;
- failure to clean and maintain equipment to prevent contamination that would alter the safety, identity, strength, quality, and purity of the drug product; and
- failure of quality unit oversight on document control and review.