FDA Inspection 998792 — Tandem Diabetes Care, Inc.
The FDA completed an inspection of Tandem Diabetes Care, Inc. on November 18, 2016 in San Diego, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 18, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3113 | 21 CFR 820.70(g) | Equipment design and installation |