FDA Inspection 1200723 — Promedtek, Inc.
The FDA completed an inspection of Promedtek, Inc. on March 22, 2023 in Scottsdale, AZ. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 22, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Scottsdale, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |