FDA Inspection 1239764 — Silgan Unicep Packaging, LLC
The FDA completed an inspection of Silgan Unicep Packaging, LLC on June 14, 2024 in Spokane, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 14, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Spokane, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |