FDA Inspection 844026 — Aidapak Services, LLC
The FDA completed an inspection of Aidapak Services, LLC on July 31, 2013 in Vancouver, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 31, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Vancouver, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 1636 | 21 CFR 211.130(e) | Packaging line inspection before use |
| 1637 | 21 CFR 211.130(e) | Packaging line inspection after use |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |