FDA Inspection 1102242 — Dynofit Inc.
The FDA completed an inspection of Dynofit Inc. on September 18, 2019 in Carrollton, TX. 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
- September 18, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Carrollton, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1 | 21 CFR 11 | Electronic records |
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |