FDA Inspection 773307 — Applied Medical Technology Inc
The FDA completed an inspection of Applied Medical Technology Inc on April 3, 2012 in Brecksville, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 3, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Brecksville, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 537 | 21 CFR 820.70(a) | Production processes |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |