FDA Inspection 1034451 — Jjgc Industria E Comercio De Materials Dentarios Sa
The FDA completed an inspection of Jjgc Industria E Comercio De Materials Dentarios Sa on Dec 7, 2017 in Curitiba. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 7, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Curitiba (Brazil)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 735 | 21 CFR 803.50(b)(3) | Conducting an Investigation |