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Five Additional Form 483s Posted, Including 4 From Japan

David McFarland

— 1 min read
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FDA 11/5 posted five additional Form FDA-483 inspection reports, including four involving manufacturers in Japan and one involving a U.S. drug outsourcing facility. The newly published records cover inspections conducted between October 2023 and September 2026. They include:

  • LeeSar Inc., Florida: Inspection dated September 23, 2026, involving a drug outsourcing facility. Form FDA-483.
  • MicroBioPharm Japan Co., Ltd., Japan: API manufacturing inspection dated February 13, 2026. Form FDA-483.
  • Yuki Gosei Kogyo Co., Ltd., Japan: API manufacturing inspection dated February 6, 2026. Form FDA-483.
  • Nissan Chemical Corporation, Japan: Manufacturing inspection dated November 21, 2025. Form FDA-483.
  • Sumitomo Osaka Cement Co., Ltd., Japan: API manufacturing inspection dated October 27, 2023. Form FDA-483.

Their availability is part of the agency’s expanded transparency initiative (see earlier story), but a significant limitation in the agency's online FOIA Electronic Reading Room makes it difficult for users to identify newly posted documents: the database does not allow records to be sorted by publication date.

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