FDA Inspection 620326 — Harris Medical Resources
The FDA completed an inspection of Harris Medical Resources on Oct 9, 2009 in Chicago, 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 9, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14525 | 21 CFR 812.2(c)(7) | Needs IDE; does not meet definition of a custom device |
| 2913 | 21 CFR 812.7(b) | Commercialization |
| 2920 | 21 CFR 812.18(b) | Exporter of investigational device |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |