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# Alembic Pharmaceuticals FDA-483 Issued
- URL: https://www.fdaweb.com/alembic-pharmaceuticals-fda-483-issued/
- Published: 2018-04-10T12:00:00.000Z
- Updated: 2026-09-14T23:58:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141187

FDA has released the FDA-483 issued following a 3/12-3/20 inspection at Alembic Pharmaceuticals Limited, Gujarat, India, an oral solid dosage drug manufacturer. Specific observations on the [form](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM604183.pdf?ref=fdaweb.com) were: 

- failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
- failing to train employees in the particular operations they perform as part of their function and written procedures required by current good manufacturing practice regulations; and
- failing to maintain written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.