FDA Inspection 655044 — Saddleback Memorial Medical Center
The FDA completed an inspection of Saddleback Memorial Medical Center on Apr 1, 2010 in Laguna Hills, 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 1, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Laguna Hills, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 161 | 21 CFR 606.160(a)(2) | Determination of lot numbers and supplies |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |