Samsung Bioepis Co., Ltd. FDA Record

Summary

FDA record by year

Samsung Bioepis Co., Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Samsung Bioepis Co., Ltd. Form 483s

2 Form 483s published by FDA.

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent recalls

1 recall record on Oct 10, 2025.

Recent FDA inspections

5 inspections from Aug 19, 2016 to Nov 22, 2024.

NAI

No objectionable conditions or practices were found during the inspection.

VAI

Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

OAI

Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

2 inspected sites, newest inspection first.

Samsung Bioepis Co., Ltd. and the FDA: common questions

Has Samsung Bioepis Co., Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Samsung Bioepis Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Samsung Bioepis Co., Ltd. received an FDA Form 483?

FDA has published 2 Form 483s for Samsung Bioepis Co., Ltd. in its reading room, the most recent dated Nov 22, 2024. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Samsung Bioepis Co., Ltd.?

The most recent FDA inspection on file ended Nov 22, 2024 at Yeonsu, Korea (The Republic Of) and was classified VAI. FDA has 5 inspections of Samsung Bioepis Co., Ltd. on file.

Has Samsung Bioepis Co., Ltd. had an FDA recall?

Yes. Samsung Bioepis Co., Ltd. has 1 FDA recall on record. The most recent started Oct 10, 2025.