926000
Alaris Biologic Technologies, Inc. — FEI 3010898668
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 13, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Gainesville, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 12326 | 21 CFR 1271.160(c) | Quality audits performed periodically |
| 12333 | 21 CFR 1271.170(b) | Not qualified, authorized for functions |
| 12345 | 21 CFR 1271.190(b)(1) | Clean, sanitary, orderly manner |
| 12353 | 21 CFR 1271.190(d)(1) | Description of methods, schedule |
| 12354 | 21 CFR 1271.190(d)(2) | Documentation of activities |
| 12356 | 21 CFR 1271.195(a) | Adequate control, proper conditions |
| 12365 | 21 CFR 1271.195(d) | Documentation not maintained |
| 12373 | 21 CFR 1271.200(d) | Inspected routinely |
| 12385 | 21 CFR 1271.150(c)(2) | Responsibility for review before distribution |
| 12402 | 21 CFR 1271.230(c) | Changes to validated process |
| 12424 | 21 CFR 1271.265(c)(1) | Release criteria verified, documented |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |