FDA Inspection 702409 — American Distilling Inc.
The FDA completed an inspection of American Distilling Inc. on December 17, 2010 in East Hampton, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 17, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- East Hampton, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 15863 | 21 CFR 111.75(a)(2)(ii)(B) | Component - certificate of analysis |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |