Drugs

FDA Posts 2 FDA-483s

FDA has posted the form FDA-483 issued following a 9/4-9/15/2023 inspection at Samsung Bioepis in Incheon, Republic of Korea, and following a 3/23-3/30/2023 inspection at Terumo Yamaguchi in Yamaguchi, Japan.

The Samsung Bioepis form lists two inspection observations:

failure to ensure proper monitoring of a study is conducted following the protocol and/or investigational plan and ensure that FDA and all investigators are promptly informed of significant new adverse effects or risks; and
failure to submit each post-marketing 15-day alert and post-marketing 15-day alert follow-up report as required.

The Terumo Yamaguchi form lists these observations:

failure to take representative samples of each shipment of each lot of components for testing or examination; and
failure to assure backup data is complete and secure from alteration, erasure, or loss through keeping hard copy or alternate systems.

FDA Posts 2 FDA-483s

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