Autumn Harp, Inc. FDA Inspection Record
Autumn Harp, Inc. is an FDA-registered facility (FEI 3006662277) located in Junction, VT, US. Registered operations: MANUFACTURE. RegDataLab tracks 7 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 30, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 7 (3 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
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 30, 2025 | Voluntary Action Indicated (VAI) | Component written specification (21 CFR 211.84(d)(2)) |
| Oct 31, 2023 | No Action Indicated (NAI) | No citations listed |
| Dec 19, 2019 | Voluntary Action Indicated (VAI) | Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Following/documenting laboratory controls (21 CFR 211.160(a)) Written records kept in individual logs (21 CFR 211.182) |
| May 14, 2015 | No Action Indicated (NAI) | Calibration/Inspection/Checking not done (21 CFR 211.68(a)) Component Test Records (21 CFR 211.184(b)) |
| Mar 12, 2012 | No Action Indicated (NAI) | No citations listed |
| Mar 12, 2012 | Voluntary Action Indicated (VAI) | Cleaning/maintenance records not kept (21 CFR 211.67(c)) Buildings not maintained in good state of repair (21 CFR 211.58) |
| Dec 4, 2009 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- Autumn Harp, Inc.
- Location
- Junction, VT (US)
- Registration Expires
- Dec 31, 2026
- Operations
- MANUFACTURE
- Source
- decrs