FDA Inspection 1240157 — Empyrean Medical Systems Inc
The FDA completed an inspection of Empyrean Medical Systems Inc on Jun 5, 2024 in Boca Raton, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 15 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 5, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Boca Raton, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 5811 | 21 CFR 1002.30(a)(1) | Quality control procedures |
| 5816 | 21 CFR 1002.30(a)(4) | Communication with dealers et. al. |