FDA Inspection 1192936 — Terumo Cardiovascular Systems Corporation
The FDA completed an inspection of Terumo Cardiovascular Systems Corporation on Dec 16, 2022 in Elkton, MD. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Dec 16, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Elkton, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |