FDA Inspection 1164781 — Albahealth LLC
The FDA completed an inspection of Albahealth LLC on March 17, 2022 in Rockwood, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 17, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rockwood, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |