FDA Inspection 582785 — Patterson Medical Holdings, Inc.
The FDA completed an inspection of Patterson Medical Holdings, Inc. on May 13, 2009 in Warrenville, 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 13, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Warrenville, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3376 | 21 CFR 820.198(e)(2) | Date complaint received |
| 3377 | 21 CFR 820.198(e)(3) | Device identification and control number |
| 3378 | 21 CFR 820.198(e)(4) | Complainant data |
| 4189 | 21 CFR 820.198(a) | General |
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |
| 4437 | 21 CFR 803.40(b) | Report of malfunction likely to cause death or injury |