FDA Inspection
Matrix Surgical Holdings, LLCMatrix Surgical Holdings, LLC – FDA Inspection, Jun 21, 2018
Record Details
This FDA Inspection record concerns Matrix Surgical Holdings, LLC, with an inspection on June 21, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 948b6dd3-19ae-46d6-9f80-618e6aef8fa8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1056391
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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