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# Fukuzyu FDA-483 Out
- URL: https://www.fdaweb.com/fukuzyu-fda-483-out/
- Published: 2026-03-03T12:00:00.000Z
- Updated: 2026-09-14T13:34:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160754

FDA has just posted the form FDA-483 issued following a 1/15-1/19/2024 inspection at the Fukuzyu Pharmaceutical Co. facility manufacturing active pharmaceutical ingredients (API) in Toyama, Japan. The inspection observations were:

- failure of the firm’s quality unit to always conduct investigations for out-of-specification results and critical deviations;
- failure to always clean and maintain shared production equipment in a manner suitable to prevent cross-contamination of non-hazardous API by hazardous substances;
- validation of analytical methods is incomplete; and
- failure to establish and follow appropriate procedures for the control of computerized systems and electronic records in the quality control laboratory.