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# FDA Hits Lupin with 5-item Form 483
- URL: https://www.fdaweb.com/fda-hits-lupin-with-5-item-form-483/
- Published: 2018-11-05T12:00:00.000Z
- Updated: 2026-09-15T00:42:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142745

FDA has issued Lupin a five-item [Form 483](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM625030.pdf?ref=fdaweb.com) after an inspection at the firm’s Madhya Pradesh, India manufacturing plant cited significant GMP violations. For example, FDA said Lupin’s control procedures are not established to monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. The 483 also said the firm’s written procedures for cleaning and maintenance failed to include descriptions in sufficient detail of methods, equipment and materials used. Additionally, it said appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records are instituted only by authorized personnel.