FDA Inspection 969808 — CEA Global Dominicana D.B.A. Nissha Medical Technologies
The FDA completed an inspection of CEA Global Dominicana D.B.A. Nissha Medical Technologies on Apr 14, 2016 in San Pedro de Macoris. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 14, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Pedro de Macoris (Dominican Republic (the))
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |