FDA Inspection 1083931 — Fairfax Cryobank, Inc.
The FDA completed an inspection of Fairfax Cryobank, Inc. on Mar 20, 2019 in Fairfax, VA. 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
- Mar 20, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fairfax, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |