FDA Inspection
Scientific ImagineticsScientific Imaginetics – FDA Inspection, Jun 23, 2010
Record Details
This FDA Inspection record concerns Scientific Imaginetics, with an inspection on June 23, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Scientific Imaginetics
- Inspection Date
- June 23, 2010
- Product Type
- Devices
View Company Profile
ID · c33f6e04-d4b7-4c37-ba84-811c9a8c2b93
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 666990
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(j)Design history file
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