FDA Inspection 797559 — Contemporary Products, LLC
The FDA completed an inspection of Contemporary Products, LLC on Aug 30, 2012 in Middletown, CT. 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
- Aug 30, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Middletown, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 4430 | 21 CFR 803.18(d)(1) | Distributor responsibilities for complaint records |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |