FDA Inspection
Amsel Medical CorporationAmsel Medical Corporation – FDA Inspection, Jun 20, 2019
Record Details
This FDA Inspection record concerns Amsel Medical Corporation, with an inspection on June 20, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b741e973-6a37-4b30-80a8-a4c45e1565a8
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1093732
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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