FDA Inspection 1101060 — Custom Healthcare Systems of VA, LLC
The FDA completed an inspection of Custom Healthcare Systems of VA, LLC on September 4, 2019 in Richmond, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 4, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Richmond, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |