FDA Inspection 793576 — Twincraft Inc.
The FDA completed an inspection of Twincraft Inc. on Jul 18, 2012 in Winooski, VT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 18, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Winooski, VT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 4345 | 21 CFR 211.160(b)(1) | Samples (various types) representative, identified properly |