FDA Inspection 772754 — Pace Tech, Inc.
The FDA completed an inspection of Pace Tech, Inc. on March 19, 2012 in Clearwater, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 19, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Clearwater, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |