FDA Inspection
Intelligent Implant SystemsIntelligent Implant Systems – FDA Inspection, Jul 16, 2018
Record Details
This FDA Inspection record concerns Intelligent Implant Systems, with an inspection on July 16, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ac867c72-a8f4-4113-a15d-c99e42566ede
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1058966
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(g)Design validation - production units
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.50(b)Supplier notification of changes
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