FDA Inspection 1210406 — Product Packaging West, Inc.
The FDA completed an inspection of Product Packaging West, Inc. on July 18, 2023 in N Hollywood, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 18, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- N Hollywood, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 3631 | 21 CFR 211.170(b) | Investigation of reserve sample deterioration |