GMT Fine Chemicals FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • Latest inspection VAI · Feb 1, 2024
  • No warning letters matched by name
Inspections 2 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

GMT Fine Chemicals has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "GMT Fine Chemicals" is on file.

What these totals cover: FDA records filed under the name "GMT Fine Chemicals".

Latest inspection
Feb 1, 2024 · VAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

2 inspections from Feb 5, 2016 to Feb 1, 2024.

DateSiteProductClassificationFEI
Feb 1, 2024Couvet, SwitzerlandDrugsVoluntary Action Indicated (VAI)3004051004
Feb 5, 2016Couvet, SwitzerlandDrugsVoluntary Action Indicated (VAI)3004051004
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.

FacilityLocationInspectionsLatest
FEI 3004051004Couvet, Switzerland2Feb 1, 2024

GMT Fine Chemicals and the FDA: common questions

Has GMT Fine Chemicals received an FDA warning letter?

No FDA warning letter addressed to the name "GMT Fine Chemicals" 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 GMT Fine Chemicals received an FDA Form 483?

FDA has not published a Form 483 for "GMT Fine Chemicals" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect GMT Fine Chemicals?

The most recent FDA inspection on file ended Feb 1, 2024 at Couvet, Switzerland and was classified VAI. FDA has 2 inspections of GMT Fine Chemicals on file.

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