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# Alkem Laboratories Inspection Findings
- URL: https://www.fdaweb.com/alkem-laboratories-inspection-findings/
- Published: 2017-03-29T12:00:00.000Z
- Updated: 2026-09-14T22:14:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138322

An FDA-483 issued at the conclusion of a 3/2-3/10 agency inspection at Alkem Laboratories, Pradesh, India, [lists](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM549106.pdf?ref=fdaweb.com) these observations: 

- failing to follow the written testing stability program;
- master production and control records lack complete manufacturing and control instructions and special notations; and
- failing to have 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.