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# Dishman Carbogen FDA-483
- URL: https://www.fdaweb.com/dishman-carbogen-fda-483/
- Published: 2018-12-11T12:00:00.000Z
- Updated: 2026-09-15T00:49:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143014

FDA has released the FDA-483 issued following a 10/22-10/26 inspection at Dishman Carbogen Amcis, a Gujarat, India, active pharmaceutical ingredient manufacturer. The two inspection observations in the [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM628090.pdf?ref=fdaweb.com) were: 

- blending of in-specification with out-of-specification intermediate batches is performed; and
- laboratory investigations for out-of-specification intermediate batches are not conducted.