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Yuki Gosei Kogyo Inspection Observations

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 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.


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