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# Yuki Gosei Kogyo Inspection Observations
- URL: https://www.fdaweb.com/yuki-gosei-kogyo-inspection-observations/
- Published: 2018-09-13T12:00:00.000Z
- Updated: 2026-09-15T00:31:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142351

FDA has released the FDA-483 issued following an 11/13-11/17/17 inspection at Yuki Gosei Kogyo, a Fukushima, Japan, active pharmaceutical ingredient (API) manufacturer. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM619909.pdf?ref=fdaweb.com) contains nine specific inspection observations: 

- laboratory control procedures are not followed;
- records associated with drug substance production and within the retention period for such records were not made readily available for authorized inspection;
- supervisory oversight over the laboratory electronic systems and data is deficient;
- the quality unit lacks adequate control of expired laboratory reagents, samples to be tested, and finished batches;
- the quality unit lacks adequate controls over GMP documents;
- document control of laboratory testing records by the quality unit is inadequate;
- equipment used in the manufacture or holding of drug components is not of appropriate design to facilitate operations for its intended use and maintenance;
- each lot in shipment received was not identified with a distinctive code for each container or grouping of containers for components; and
- equipment used during laboratory operations and production of an intermediate or API are not appropriately identified.