FDA Inspection 747074 — Providence Health System Southern California
The FDA completed an inspection of Providence Health System Southern California on September 27, 2011 in Burbank, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 27, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Burbank, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 61 | 21 CFR 606.60(a) | Provide proper equipment to meet requirements |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9089 | 21 CFR 600.14(c) | When to report |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |