FDA Inspection 663234 — Ra Medical Systems, Inc.
The FDA completed an inspection of Ra Medical Systems, Inc. on May 24, 2010 in Carlsbad, CA. 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
- May 24, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Carlsbad, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |