FDA 483 - Meiji Seika Pharma Co., Ltd. - Gifu Plant - September 02, 2022

This FDA Form 483 document details observations made during an inspection of Meiji Seika Pharma Co., Ltd., an API Manufacturer located at 2890 Kitagata, Kitagata-Cho, Motosu-Gun, Gifu, 501-0131, Japan. The inspection was conducted from August 29, 2022, to September 2, 2022.

The inspection revealed three observations:

1. **Quality System Deficiency:** Failure to have a quality control unit independent of production that fulfills quality assurance (QA) and quality control (QC) duties. Specifically, the company's procedure "Roles and Responsibilities of Operations related to GMP" states the QA manager is responsible for reviewing validation protocols and reports, while the Validation Manager is responsible for approving validation protocols, reports, and releasing equipment for production. Validation Master Plans for the production of (b)(4) and related validation activities were approved by the Validation Manager, indicating a lack of independence.

2. **Facilities and Equipment System Deficiency (Computerized Systems):** Failure to exercise sufficient controls over computerized systems to prevent unauthorized printing of drug substance labels. Specifically, Computer Tag No. 10020792, used for printing (b)(4) and (b)(4) finished product and shipping labels, does not require a unique username and password for access to print labels. Additionally, the (b)(4)