FDA Inspection 938568 — BURTON MEDICAL
The FDA completed an inspection of BURTON MEDICAL on Aug 4, 2015 in Addison, IL. 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
- Aug 4, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Addison, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3372 | 21 CFR 820.198(d) | Records of MDR Investigation |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |