FDA Inspection 1095119 — Veterans Affairs Long Beach Health Care System
The FDA completed an inspection of Veterans Affairs Long Beach Health Care System on July 2, 2019 in Long Beach, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 2, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Long Beach, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9044 | 21 CFR 600.10(b) | Personnel capabilities |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |