FDA Inspection 1107709 — Airsep Corporation
The FDA completed an inspection of Airsep Corporation on October 25, 2019 in Amherst, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 25, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Amherst, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |