Hugel Inc. FDA Record

Summary

Hugel Inc. 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 FDA inspections

1 inspection on Oct 19, 2023.

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

1 inspected site, newest inspection first.

Hugel Inc. and the FDA: common questions

Has Hugel Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Hugel Inc." 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 Hugel Inc. received an FDA Form 483?

FDA has published 2 Form 483s for Hugel Inc. in its reading room, the most recent dated Mar 10, 2023. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Hugel Inc.?

The most recent FDA inspection on file ended Oct 19, 2023 at Chuncheon, Korea (The Republic Of) and was classified VAI. FDA has 1 inspection of Hugel Inc. on file.