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# 6 Observations in Cipla FDA-483
- URL: https://www.fdaweb.com/6-observations-in-cipla-fda-483/
- Published: 2024-04-11T12:00:00.000Z
- Updated: 2026-09-14T14:28:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156755

FDA has released the form FDA-483 issued following a 3/28-4/4 inspection at the Cipla Limited facility in Raigad, Maharashtra, India, that manufactures human and animal active pharmaceutical ingredients (API) and human drug products. The six inspection observations were:

- failure to clean and maintain equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the API beyond the official or other established specifications;
- failure to clean and maintain equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product;
- failure to adequately investigate out-of-specification results;
- failure to follow equipment qualification procedures;
- failure to ensure all production deviations are reported and evaluated and that critical deviations are investigated and the conclusions are recorded; and
- failure to fully follow the responsibilities and procedures applicable to the quality control unit.