FDA Inspection 1003680 — Terumo Medical Corporation
The FDA completed an inspection of Terumo Medical Corporation on January 13, 2017 in Elkton, MD. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 13, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Elkton, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14715 | 21 CFR 820.30(d) | Design output - Lack of or inadequate procedures |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |