FDA Inspection 770919 — 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 Feb 2, 2012 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 2, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- San Pedro de Macoris (Dominican Republic (the))
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |