FDA Inspection 703440 — QED, Inc.
The FDA completed an inspection of QED, Inc. on January 21, 2011 in Lexington, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 21, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lexington, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3270 | 21 CFR 820.80(c) | Documentation |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3696 | 21 CFR 820.100(b) | Documentation |