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# Ipca Laboratories FDA-483
- URL: https://www.fdaweb.com/ipca-laboratories-fda-483/
- Published: 2023-05-16T12:00:00.000Z
- Updated: 2026-09-14T18:32:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154459

FDA has just released the form FDA-483 issued following a 4/18-4/26 inspection at the Ipca Laboratories drug manufacturing facility in Haveli, India. The three inspection observations 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 been already distributed;
- failing to maintain in writing and fully follow the responsibilities and procedures applicable to the quality control unit; and
- failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.