FDA Inspection
EPflex Feinwerktechnik GmbHEPflex Feinwerktechnik GmbH – FDA Inspection, Sep 19, 2024
Record Details
This FDA Inspection record concerns EPflex Feinwerktechnik GmbH, with an inspection on September 19, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- EPflex Feinwerktechnik GmbH
- Inspection Date
- September 19, 2024
- Product Type
- Medical Devices & Rad Health
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ID · 7bf05d18-44bc-43f8-9364-fe80723bc1bc
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1249545
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of EPflex Feinwerktechnik GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 26, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 13, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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