FDA Inspection 611156 — Orthomerica Products, Inc.
The FDA completed an inspection of Orthomerica Products, Inc. on Sep 10, 2009 in Orlando, 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 10, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 4189 | 21 CFR 820.198(a) | General |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |