FDA Inspection
XAVANT TECHNOLOGY (PTY) LTDXAVANT TECHNOLOGY (PTY) LTD – FDA Inspection, Mar 16, 2017
Record Details
This FDA Inspection record concerns XAVANT TECHNOLOGY (PTY) LTD, with an inspection on March 16, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 0f103f29-2a94-446b-86ca-3f13c1aa86f4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1008355
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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