FDA Inspection 1259242 — Scapa Tapes North America LLC
The FDA completed an inspection of Scapa Tapes North America LLC on Jan 23, 2025 in Knoxville, TN. 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
- Jan 23, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Knoxville, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |