FDA Inspection 1153156 — NEUROLOGICAL FITNESS EQUIPMENT And EDUCATION LLC
The FDA completed an inspection of NEUROLOGICAL FITNESS EQUIPMENT And EDUCATION LLC on Sep 29, 2021 in Austin, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 29, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |