FDA Inspection 1014737 — Contract Supplement Packaging, LLC
The FDA completed an inspection of Contract Supplement Packaging, LLC on June 16, 2017 in Boise, ID. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 16, 2017
- Fiscal Year
- 2017
- 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 |
| 1545 | 21 CFR 211.125(c) | Label reconciliation discrepancies evaluation/investigation |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4375 | 21 CFR 211.188(b)(5) | In-process and laboratory control results |
| 4576 | 21 CFR 211.192 | No written record of investigation |