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# Sun Pharma Gets 8-item FDA-483
- URL: https://www.fdaweb.com/sun-pharma-gets-8-item-fda-483/
- Published: 2020-01-06T12:00:00.000Z
- Updated: 2026-09-14T15:57:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145767

FDA has issued Sun Pharmaceutical Industries an [eight-observation Form 483](https://www.fda.gov/media/133737/download?ref=fdaweb.com) after a December inspection at its Gujarat, India drug manufacturing facility. According to the form, the company was cited for not having written procedures for production and process controls designed to assure that its drug products have the identity, strength, quality, and purity they purport to possess.

Sun was also cited for not specifying in writing the responsibilities and procedures applicable to the quality control unit. Specifically, the 483 said the company failed to establish and implement controls which ensure data integrity when using its environmental monitoring computerized system for microbiology samples, including all sterile environmental monitoring. It said the microbiology laboratory failed to establish controls which monitor and prevent all environmental monitoring data from being manipulated.

Additionally, FDA said Sun’s laboratory controls do not include scientifically sound and appropriate test procedures designed to assure that its drug products conform to appropriate standards of identity, strength, quality and purity. And, it said, control procedures are not established which monitor the output of identified manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and drug products.