FDA Inspection 1078569 — PCI San Diego, Inc.
The FDA completed an inspection of PCI San Diego, Inc. on Feb 7, 2019 in San Diego, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 7, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1431 | 21 CFR 211.42(c)(10)(ii) | Temperature / Humidity Controls |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1504 | 21 CFR 211.122(d) | Labels and labeling stored separately |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |