Autumn Harp, Inc. FDA Record

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

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

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

Latest inspection
Apr 30, 2025 · VAI

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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
Inspections7Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Autumn Harp, Inc.: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 1 inspections120232024: 0 inspections020242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202310000
202200000
202100000
202000000
201910000
201800000
201700000

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.

Recent FDA inspections

7 inspections from Dec 4, 2009 to Apr 30, 2025.

DateSiteProductClassificationFEI
Apr 30, 2025Essex Junction, VTDrugsVoluntary Action Indicated (VAI)3006662277
Oct 31, 2023Essex Junction, VTFood/CosmeticsNo Action Indicated (NAI)3006662277
Dec 19, 2019Essex Junction, VTDrugsVoluntary Action Indicated (VAI)3006662277
May 14, 2015Essex Junction, VTDrugsNo Action Indicated (NAI)3006662277
Mar 12, 2012Essex Junction, VTDrugsVoluntary Action Indicated (VAI)3006662277
Mar 12, 2012Essex Junction, VTDrugsNo Action Indicated (NAI)3006662277
Dec 4, 2009Essex Junction, VTDrugsNo Action Indicated (NAI)3006662277
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 3006662277Essex Junction, VT7Apr 30, 2025

Autumn Harp, Inc. and the FDA: common questions

Has Autumn Harp, Inc. received an FDA warning letter?

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

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

When did the FDA last inspect Autumn Harp, Inc.?

The most recent FDA inspection on file ended Apr 30, 2025 at Essex Junction, VT and was classified VAI. FDA has 7 inspections of Autumn Harp, Inc. on file.

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