FDA Inspection 1202513 — Netech Corp.
The FDA completed an inspection of Netech Corp. on April 14, 2023 in Farmingdale, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 14, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Farmingdale, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |