FDA Inspection
Jjgc Industria E Comercio De Materials Dentarios SaJjgc Industria E Comercio De Materials Dentarios Sa – FDA Inspection, Dec 7, 2017
Record Details
This FDA Inspection record concerns Jjgc Industria E Comercio De Materials Dentarios Sa, with an inspection on December 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 7, 2017
- Product Type
- Devices
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ID · c5e98545-fe6e-4cfb-a055-0bbb91b6382a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034451
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 803.50(b)(3)Conducting an Investigation
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.70(i)Software validation for automated processes
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