1155083
Aire-Master of America Inc — FEI 3002764676
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 19, 2021
- Fiscal Year
- 2022
- 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 |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 21295 | 21 CFR 211.110(b) | In-process conformity - examination, sample testing |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |