FDA Inspection 651132 — Air Techniques Inc
The FDA completed an inspection of Air Techniques Inc on February 5, 2010 in Melville, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 5, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Melville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |