> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Cohance Lifescience FDA-483
- URL: https://www.fdaweb.com/cohance-lifescience-fda-483/
- Published: 2025-09-23T12:00:00.000Z
- Updated: 2026-09-14T15:22:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159919

FDA has released the form FDA-483 issued following an 8/4-8/12 inspection at the Cohance Lifesciences drug manufacturing facility in Secunderabad, Telangana, India. The inspection observations were:

- failure 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 had already been distributed;
- failure of written records of investigations of a drug complaint to include the follow-up;
- failure to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit;
- failure to clean, maintain, and sanitize 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 establish written procedures for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product; and
- failure to establish the accuracy, sensitivity, and reproducibility of test methods.