FDA Inspection 656377 — Silgan Unicep Packaging, LLC
The FDA completed an inspection of Silgan Unicep Packaging, LLC on March 16, 2010 in Sandpoint, ID. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 18 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 16, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sandpoint, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4404 | 21 CFR 211.194(a)(1) | Sample identification and other information |
| 4405 | 21 CFR 211.194(a)(2) | Statement of methods and data |
| 4407 | 21 CFR 211.194(a)(2) | Reference and method not stated |
| 4408 | 21 CFR 211.194(a)(3) | Weight or measure of sample |
| 4409 | 21 CFR 211.194(a)(4) | Data secured in course of each test |
| 4410 | 21 CFR 211.194(a)(5) | Calculations performed are in the records |
| 4412 | 21 CFR 211.194(a)(7) | Signatures and dates--person who performs test |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |