FDA Inspection 969945 — Air Techniques Inc
The FDA completed an inspection of Air Techniques Inc on April 29, 2016 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
- April 29, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Melville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |