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# FDA Posts 2 FDA-483s
- URL: https://www.fdaweb.com/fda-posts-2-fda-483s/
- Published: 2024-09-25T12:00:00.000Z
- Updated: 2026-09-14T14:42:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157852

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](http://www.fda.gov/media/182190/download?ref=fdaweb.com) 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](http://www.fda.gov/media/182191/download?ref=fdaweb.com) 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.