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# Zydus Lifesciences FDA-483 Out
- URL: https://www.fdaweb.com/zydus-lifesciences-fda-483-out/
- Published: 2025-10-30T12:00:00.000Z
- Updated: 2026-09-14T15:25:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160132

FDA has released the form FDA-483 issued following an 8/4-8/13 inspection at the Zydus Lifesciences drug manufacturing facility in Baddi, Himachal, Pradesh, India. The inspection observations were:

- failure to fully follow the responsibilities and procedures applicable to the quality control unit;
- procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed;
- failure to examine visually at least once a year for evidence of deterioration, reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures; and
- failure to clean equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product.