> ## 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.

# FDA Releases Suven Life Sciences FDA-483
- URL: https://www.fdaweb.com/fda-releases-suven-life-sciences-fda-483/
- Published: 2018-04-26T12:00:00.000Z
- Updated: 2026-09-15T00:01:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141312

FDA has released the FDA-483 issued following a 2/5-2/15 inspection at Suven Life Sciences Limited, Telangana, India. The inspection observations [were](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM605497.pdf?ref=fdaweb.com): 

- appropriate controls are not exercised over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel;
- equipment and utensils are not cleaned and maintained to prevent contamination that would alter the safety, identity, strength, quality, or purity of the intermediates and active pharmaceutical ingredients manufactured;
- manufacturing batch records are deficient;
- procedures for sampling of raw materials were not followed;
- · label access is not controlled;
- employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training required to perform their assigned functions; and
- the firm’s product quality reviews are deficient.