FDA Inspection 1086050 — Bite Tech Inc.
The FDA completed an inspection of Bite Tech Inc. on April 11, 2019 in Norwalk, CT. 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
- April 11, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Norwalk, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |