FDA Inspection 987207 — Alaris Biologic Technologies, Inc.
The FDA completed an inspection of Alaris Biologic Technologies, Inc. on April 29, 2016 in Gainesville, FL. 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
- 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 |