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# Sumitomo Pharma Gets FDA-483 After Inspection
- URL: https://www.fdaweb.com/sumitomo-pharma-gets-fda-483-after-inspection/
- Published: 2025-10-24T12:00:00.000Z
- Updated: 2026-09-14T15:25:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160102

FDA has posted a two-item Form FDA-483 from an August inspection of Sumitomo Pharma’s Suzuka, Japan, manufacturing facility that cited GMP deficiencies. The agency cited the firm over its sampling procedures involving incoming raw materials and excipients. It said Sumitomo had not established a documented rationale or scientific justification to support the facility’s practice. Additionally, the agency took exception to the firm’s procedures used to prevent objectionable microorganisms in its drug products.