FDA Inspection 1070631 — We Pack It All LLC
The FDA completed an inspection of We Pack It All LLC on Nov 1, 2018 in Duarte, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Nov 1, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Duarte, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3607 | 21 CFR 211.160(b)(2) | Acceptance of in-process materials |
| 3610 | 21 CFR 211.160(b)(3) | Drug product sample |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |