FDA Inspection
Anewmed CorporationAnewmed Corporation – FDA Inspection, Jun 28, 2018
Record Details
This FDA Inspection record concerns Anewmed Corporation, with an inspection on June 28, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 81c435ae-439d-44e8-9a17-9b7514431f0a
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1057908
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of Anewmed Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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