FDA Inspection 1107407 — Cerapedics, Inc.
The FDA completed an inspection of Cerapedics, Inc. on October 24, 2019 in Westminster, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 24, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Westminster, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |