FDA Inspection 826079 — EPSILON IMAGING, INC
The FDA completed an inspection of EPSILON IMAGING, INC on Mar 28, 2013 in Ann Arbor, MI. 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). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 28, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ann Arbor, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3208 | 21 CFR 820.50(b) | Approval of purchasing data {see also 820.40(a)} |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |