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# Ipca Laboratories FDA-483
- URL: https://www.fdaweb.com/ipca-laboratories-fda-483-2/
- Published: 2019-09-10T12:00:00.000Z
- Updated: 2026-09-15T01:48:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144970

FDA has released the FDA-483 issued following an 8/19-8/23 inspection at Ipca Laboratories, Silvasa, India. The four inspection [observations](https://www.fda.gov/media/130650/download?ref=fdaweb.com) were: 

- deviations from written test procedures and laboratory mechanisms are not recorded and justified;
- 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 been already distributed; and
- failing to fully follow responsibilities and procedures applicable to the quality control unit.