FDA Inspection 855467 — Dexcom, Inc.
The FDA completed an inspection of Dexcom, Inc. on November 7, 2013 in San Diego, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 7, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- San Diego, CA (United States)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |
| 637 | 21 CFR 803.17(b) | Information used for annual reports |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |