FDA Inspection 848609 — Lucero Medical LLC
The FDA completed an inspection of Lucero Medical LLC on September 12, 2013 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 12, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Richfield, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |