FDA Inspection 1035323 — Blood Assurance Inc.
The FDA completed an inspection of Blood Assurance Inc. on Dec 19, 2017 in Hixson, TN. 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). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 19, 2017
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Hixson, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |