FDA Inspection 582411 — Contract Supplement Packaging, LLC
The FDA completed an inspection of Contract Supplement Packaging, LLC on April 23, 2009 in Boise, ID. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 23, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Boise, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 3548 | 21 CFR 211.46(c) | Air filtration system lacking in production area |
| 4316 | 21 CFR 211.84(d)(3) | Testing Containers & Closures Conformity with Specs |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |