FDA Inspection 1083206 — Excel Medical Electronics LLC
The FDA completed an inspection of Excel Medical Electronics LLC on March 13, 2019 in Palm Bch Gdns, FL. 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
- March 13, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Palm Bch Gdns, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3323 | 21 CFR 820.170(b) | Installer records |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |