987207
Alaris Biologic Technologies, Inc. — FEI 3010898668
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 29, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Gainesville, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |
| 12310 | 21 CFR 1271.160(a) | All core requirements covered in program |
| 12326 | 21 CFR 1271.160(c) | Quality audits performed periodically |
| 12441 | 21 CFR 1271.270(c) | Back-up of electronic records |
| 15020 | 21 CFR 1271.200(e) | Documentation of maintenance and cleaning |