FDA Inspection 595700 — Mercedes Medical, Inc.
The FDA completed an inspection of Mercedes Medical, Inc. on Jul 9, 2009 in Lakewood Ranch, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 12 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 9, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lakewood Ranch, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3250 | 21 CFR 820.72(b)(2) | Calibration documentation |
| 3343 | 21 CFR 820.198(e) | Maintained |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |