FDA 483 - Unknown Company - March 29, 2023

An FDA inspection of Japan Food Research Laboratories, a contract laboratory located in Osaka, Japan, was conducted from March 21-29, 2023. The inspection identified several deficiencies in their quality system and laboratory controls.

**Key Observations:**

1. **Inadequate Employee Training:** Employees, specifically Ms. Kawanishi and Mr. Sato, appeared insufficiently informed about quality-related procedures, including training, complaints, Quality Unit responsibilities, equipment qualifications, and Out-of-Specification (OOS) controls. Their training program was deemed deficient, with Mr. Sato having been trained on approximately 21 SOPs on January 13, 2021.

2. **Lack of Quality Control Unit Authority:** The Quality Control (QC) unit lacked the authority to fully investigate errors. For instance, in an OOS report for (b)(4), the QA had not initiated investigations and only notified the customer. The QA manager stated that procedures are issued by the QC Head and the QA.

3. **Unwritten Quality Control Unit Responsibilities:** The responsibilities and procedures for the quality control unit were not in writing. Specifically, the firm failed to provide a procedure for water sampling, testing, and sanitation.

4. **Deficient OOS Retesting Procedures:** The firm's procedure for retesting OOS results was deficient. An assay test result for (b)(4) on August 12