FDA Inspection 1127641 — Twincraft Inc.
The FDA completed an inspection of Twincraft Inc. on Aug 25, 2020 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 25, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Winooski, VT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1371 | 21 CFR 211.101(a) | Batches Formulated to less than 100% |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 2405 | 21 CFR 211.194(a)(7) | Identification of Person Performing the Testing |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |