896921
Air Techniques Inc — FEI 2428225
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 12, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Melville, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3159 | 21 CFR 820.184 | DHR content |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3682 | 21 CFR 820.70(d) | Implementing Personnel Procedures, Health, Cleanliness. |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |