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# FDA Issues Lupin 6-item Form 483 After Inspection
- URL: https://www.fdaweb.com/fda-issues-lupin-6-item-form-483-after-inspection/
- Published: 2017-06-02T12:00:00.000Z
- Updated: 2026-09-14T22:27:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138842

A just-completed FDA inspection of Lupin Ltd.’s Madhya Pradesh, India manufacturing facility has resulted in a six-observation [Form 483](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM561583.pdf?ref=fdaweb.com) related to GMP deviations at the plant. For example, agency investigators said the firm invalidated 96% of all the out-of-specification results obtained during testing of commercial drug products during the last two years. They also cited it for inadequate written records of investigations because they do not include conclusions and follow-up. Additionally, the agency said there are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality and purity they purport to possess.