FDA Inspection
Kerber USA Inc.Kerber USA Inc. – FDA Inspection, Nov 7, 2025
Record Details
This FDA Inspection record concerns Kerber USA Inc., with an inspection on November 7, 2025, issued by the New York District Office, covering medical devices & rad health.
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ID · ca754e24-7848-42c7-8bd0-e5a92208a12d
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1291292
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
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Other FDA inspections of Kerber USA Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 2, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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