FDA Inspection 1215085 — ACI Medical LLC
The FDA completed an inspection of ACI Medical LLC on August 17, 2023 in San Marcos, CA. 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
- August 17, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Marcos, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 21425 | 21 CFR 820.184(f) | DHR - UDI not included |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |