FDA Inspection 613158 — American Distilling Inc.
The FDA completed an inspection of American Distilling Inc. on September 4, 2009 in East Hampton, CT. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 4, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- East Hampton, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |