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# Unichem Laboratories FDA-483
- URL: https://www.fdaweb.com/unichem-laboratories-fda-483/
- Published: 2018-09-13T12:00:00.000Z
- Updated: 2026-09-15T00:31:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142354

FDA has released the FDA-483 issued following a 7/23-7/27 inspection at Unichem Laboratories, Pithampur, Dhar, India. Specific [observations](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM619907.pdf?ref=fdaweb.com) at the drug manufacturing firm were: 

- cleaning procedures are not validated;
- test procedures are not scientifically sound and appropriate to ensure that raw materials, intermediates, APIs, and labels and packaging materials conform to established standards of quality and/or purity;
- laboratory controls were not followed and documented at the time of performance; and
- there was no record of stability samples stored in containers that simulate the market container.