FDA Inspection 629716 — Magnificent Medical Equipment, Inc. DBA Tony Riso Company
The FDA completed an inspection of Magnificent Medical Equipment, Inc. DBA Tony Riso Company on November 19, 2009 in Hobe Sound, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 19, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hobe Sound, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3157 | 21 CFR 820.181(c) | DMR QA procedures and specifications |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3268 | 21 CFR 820.80(b) | Incoming inspection, testing, verification |
| 3380 | 21 CFR 820.198(e)(6) | Results of investigation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4189 | 21 CFR 820.198(a) | General |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 537 | 21 CFR 820.70(a) | Production processes |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |