FDA Inspection 550114 — Marina Medical Instruments Inc.
The FDA completed an inspection of Marina Medical Instruments Inc. on December 5, 2008 in Davie, 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
- December 5, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Davie, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3380 | 21 CFR 820.198(e)(6) | Results of investigation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 4058 | 21 CFR 820.20 | Management responsibility |
| 4189 | 21 CFR 820.198(a) | General |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 538 | 21 CFR 820.70(a) | Process control procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |