FDA Inspection
Autumn HarpAutumn Harp – FDA Inspection, Dec 19, 2019
Record Details
This FDA Inspection record concerns Autumn Harp, with an inspection on December 19, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Autumn Harp
- Inspection Date
- December 19, 2019
- Product Type
- Drugs
View Company Profile
ID · c09d89ee-7c4d-48cb-9270-7cdcdf5da77b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1113587
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.182Written records kept in individual logs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Autumn Harp
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 30, 2025 | VAI | New England District Office | Drug Quality Assurance |
| October 31, 2023 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| May 14, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 12, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 12, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Autumn Harp
- FDA Inspection 1268730 - 2025-04-30
- FDA Inspection 1224074 - 2023-10-31
- FDA Inspection 929230 - 2015-05-14
- FDA Inspection 779445 - 2012-03-12
- FDA Inspection 774574 - 2012-03-12
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.