FDA Inspection 1178977 — Lucero Medical LLC
The FDA completed an inspection of Lucero Medical LLC on September 7, 2022 in Richfield, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 7, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Richfield, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |