FDA Inspection 1053096 — Portable Therapeutix
The FDA completed an inspection of Portable Therapeutix on May 24, 2018 in Houston, 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 24, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14711 | 21 CFR 820.160(a) | Lack of or inadequate procedures for distribution |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3696 | 21 CFR 820.100(b) | Documentation |