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Twincraft Inc. FDA Record

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

Twincraft Inc. has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Twincraft Inc." is on file.

What these totals cover: FDA records filed under the name "Twincraft Inc." and its spelling variant "Twincraft".

Latest inspection: Apr 22, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	7	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	2	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	1	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	1	0	0	0	0

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.

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Recent FDA inspections

7 inspections from Sep 9, 2010 to Apr 22, 2025.

Date	Site	Product	Classification	FEI
Apr 22, 2025	Winooski, VT	Drugs	No Action Indicated (NAI)	1219963
Feb 6, 2025	Essex Junction, VT	Food/Cosmetics	No Action Indicated (NAI)	3010000979
Aug 25, 2020	Winooski, VT	Drugs	Voluntary Action Indicated (VAI)	1219963
Aug 3, 2017	Winooski, VT	Food/Cosmetics	No Action Indicated (NAI)	1219963
Jun 25, 2015	Winooski, VT	Drugs	No Action Indicated (NAI)	1219963
Jul 18, 2012	Winooski, VT	Drugs	Voluntary Action Indicated (VAI)	1219963
Sep 9, 2010	Winooski, VT	Drugs	No Action Indicated (NAI)	1219963

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.

Facility	Location	Inspections	Latest
FEI 1219963	Winooski, VT	6	Apr 22, 2025
FEI 3010000979	Essex Junction, VT	1	Feb 6, 2025

Twincraft Inc. and the FDA: common questions

Has Twincraft Inc. received an FDA warning letter?

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

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

When did the FDA last inspect Twincraft Inc.?

The most recent FDA inspection on file ended Apr 22, 2025 at Winooski, VT and was classified NAI. FDA has 7 inspections of Twincraft Inc. on file.

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