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Hugel, Inc. FDA Inspection Record

FEI 3012163998 · Inspections, Form 483s, warning letters and import refusals

Hugel, Inc. is an FDA-registered facility (FEI 3012163998) located in South (KOR). Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK. RegDataLab tracks 1 FDA inspection at this facility.

What FDA found at this site

Latest inspection
Oct 19, 2023: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
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
Import refusals
8

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
Oct 19, 2023Voluntary Action Indicated (VAI)No citations listed

Form 483s and inspection documents

  • 483 on FDA.gov
    Inspection Feb 27, 2023 to Mar 10, 2023 (dates printed on the document). FDA listing date Mar 10, 2023. Published by FDA Sep 23, 2024.
  • 483 on FDA.gov
    Inspection Aug 12, 2021 to Aug 20, 2021 (dates printed on the document). FDA listing date Aug 20, 2021. Published by FDA Sep 6, 2022.

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
Hugel Inc.
Location
South (KOR)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK
Source
decrs

Import refusals

FDA data resources

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