FDA Inspection 862780 — Marina Medical Instruments Inc.
The FDA completed an inspection of Marina Medical Instruments Inc. on January 9, 2014 in Davie, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 9, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Davie, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 14721 | 21 CFR 820.70(g)(2) | Periodic equipment inspections |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |