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# Form 483 Issued to Chugai After Inspection
- URL: https://www.fdaweb.com/form-483-issued-to-chugai-after-inspection/
- Published: 2024-06-17T12:00:00.000Z
- Updated: 2026-09-14T14:33:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157196

FDA has issued a one-item [Form FDA-483](https://www.fda.gov/media/179391/download?ref=fdaweb.com) to Chugai Pharma Manufacturing Co. after inspecting the firm’s Utsunomiya, Tochigi, Japan facility 3/25 to 4/2\. The agency cited Chugai over its procedures for preventing microbiological contamination of drug products because they did not include adequate validation of the aseptic process. Specifically, FDA says the facility’s recent smoke study that was conducted as part of its validation of an undisclosed piece of equipment did not accurately simulate actual processing conditions.