FDA Inspection 904912 — Pasadena Hospital Association, Ltd.
The FDA completed an inspection of Pasadena Hospital Association, Ltd. on Nov 14, 2014 in Pasadena, 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 14, 2014
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Pasadena, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 158 | 21 CFR 606.160(e)(1) | Donor deferral record - each location |
| 98 | 21 CFR 606.100(c) | Thorough investigations |