FDA Inspection 1191438 — Custom Healthcare Systems of VA, LLC
The FDA completed an inspection of Custom Healthcare Systems of VA, LLC on October 26, 2022 in Richmond, VA. 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
- October 26, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Richmond, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3264 | 21 CFR 820.250(b) | Sampling methods - Lack of or inadequate procedures |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |