995620
Aire-Master of America Inc — FEI 3002764676
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 14, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Nixa, MO (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |