FDA Inspection 1042813 — Alaris Biologic Technologies, Inc.
The FDA completed an inspection of Alaris Biologic Technologies, Inc. on March 2, 2018 in Gainesville, FL. 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
- March 2, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Gainesville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12400 | 21 CFR 1271.230(a) | Documented, dated, signed |
| 12402 | 21 CFR 1271.230(c) | Changes to validated process |
| 12473 | 21 CFR 1271.350(b)(2) | Deviations not reported to FDA |