FDA Inspection
Newman MedicalNewman Medical – FDA Inspection, May 31, 2019
Record Details
This FDA Inspection record concerns Newman Medical, with an inspection on May 31, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6fec244f-83f3-47a8-8a86-708ced54c59a
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1091306
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of Newman Medical
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2024 | NAI | Denver District Office | Postmarket Assurance: Medical Devices |
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