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Samsung Bioepis Co., Ltd. FDA Inspection Record

FEI 3010031951 · Inspections, Form 483s, warning letters and import refusals

Samsung Bioepis Co., Ltd. is an FDA-registered facility (FEI 3010031951) located in South (KOR). Registered operations: ANALYSIS. RegDataLab tracks 4 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Nov 22, 2024: Voluntary Action Indicated (VAI)
Inspections on record
4 (3 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Form 483 and inspection documents
2 in FDA's reading room
Recalls as the recalling firm
1, latest Oct 10, 2025
Import refusals
1

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Nov 22, 2024Voluntary Action Indicated (VAI)No citations listed
Sep 15, 2023Voluntary Action Indicated (VAI)General responsibilities of sponsors (21 CFR 312.50)
Reporting Requirements - submission of reports (21 CFR 600.80(c)(1)(iii))
Feb 15, 2019No Action Indicated (NAI)No citations listed
Aug 19, 2016Voluntary Action Indicated (VAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Oct 10, 2025Class IID-0099-2026HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per…
Lack of Assurance of Sterility.

Form 483s and inspection documents

  • 483 on FDA.gov
    FDA listing date Nov 22, 2024, which is not always the inspection or issue date. Published by FDA May 23, 2025.
  • 483 on FDA.gov
    Inspection Sep 4, 2023 to Sep 15, 2023 (dates printed on the document). FDA listing date Sep 15, 2023. Published by FDA Sep 25, 2024.

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Samsung Bioepis Co., Ltd.
Location
South (KOR)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS
Source
decrs

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.