FDA Inspection 991555 — Althea US, Inc.
The FDA completed an inspection of Althea US, Inc. on November 4, 2016 in Goodlettsville, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 4, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Goodlettsville, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5905 | 21 CFR 1020.30(d) | Assembling, installing, adjusting, testing |
| 5907 | 21 CFR 1020.30(d)(1) | Report of assembly submitted within 15 days |