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Twincraft Inc. FDA Inspection Record

FEI 1219963 · Inspections, Form 483s, warning letters and import refusals

Twincraft Inc. is an FDA-inspected facility (FEI 1219963) located in Winooski, VT, US. RegDataLab tracks 6 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 22, 2025: No Action Indicated (NAI)
Inspections on record
6 (2 VAI, 4 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
Import refusals
10 or more

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
Apr 22, 2025No Action Indicated (NAI)No citations listed
Aug 25, 2020Voluntary Action Indicated (VAI)Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Batches Formulated to less than 100% (21 CFR 211.101(a))
Procedures for non-sterile drug products (21 CFR 211.113(a))
Identification of Person Performing the Testing (21 CFR 211.194(a)(7))
and 2 more
Aug 3, 2017No Action Indicated (NAI)No citations listed
Jun 25, 2015No Action Indicated (NAI)Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Following/documenting laboratory controls (21 CFR 211.160(a))
Personnel dating/signing equipment log (21 CFR 211.182)
Jul 18, 2012Voluntary Action Indicated (VAI)Written procedures not established/followed (21 CFR 211.67(b))
Written records kept in individual logs (21 CFR 211.182)
Equipment for Environmental Control (21 CFR 211.46(b))
Samples (various types) representative, identified properly (21 CFR 211.160(b)(1))
Sep 9, 2010No Action Indicated (NAI)No citations listed

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
Twincraft Inc.
Location
Winooski, VT (US)
Source
inspections

Import refusals

FDA data resources

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