FDA Inspection 853591 — Healthy Spirit, LLC
The FDA completed an inspection of Healthy Spirit, LLC on October 29, 2013 in Baltimore, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 29, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Baltimore, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3668 | 21 CFR 820.20(c) | Management review dates |