FDA Inspection 613324 — Munroe Regional Medical Center Clinical Laboratory
The FDA completed an inspection of Munroe Regional Medical Center Clinical Laboratory on Sep 21, 2009 in Ocala, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 21, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ocala, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 621 | 21 CFR 803.11 | Failure to use FDA Form 3500A |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |
| 642 | 21 CFR 803.18(b)(1)(i) | Adverse events--all info not in file |