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# Violations at India’s Granules Omnichem
- URL: https://www.fdaweb.com/violations-at-indias-granules-omnichem/
- Published: 2017-01-25T12:00:00.000Z
- Updated: 2026-09-14T22:02:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137824

FDA has released an FDA-483 issued following a 12/5-12/9/16 inspection at Granules Omnichem Private Limited, Visakhapatnarn, India. The [document](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM536069.pdf?ref=fdaweb.com) lists these deviations from current good manufacturing practice regulations for active pharmaceutical ingredients: 

- failure of the quality unit to ensure review of all deviations reported during production before final product batch release;
- failing to train an employee before conducting cleaning of the microbiology laboratory ISO Class 8 room;
- failure of the change control system to evaluate and reflect all changes that may affect the production of the finished product;
- failing to have complete production master batch records;
- failing to have laboratory control records include complete data derived from all tests conducted to ensure compliance with established specifications and standards, including examinations and assays;
- facility design and maintenance increases the potential for contamination of equipment and product; and
- failing to handle and store materials in a way to prevent degradation, contamination, and cross-contamination.