FDA Inspection
EPflex Feinwerktechnik GmbHEPflex Feinwerktechnik GmbH – FDA Inspection, Jun 13, 2013
Record Details
This FDA Inspection record concerns EPflex Feinwerktechnik GmbH, with an inspection on June 13, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- EPflex Feinwerktechnik GmbH
- Inspection Date
- June 13, 2013
- Product Type
- Devices
View Company Profile
ID · a26f4392-a27e-4d8a-9e6e-a8b0b5d37dfb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 839372
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.184DHR content
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Other FDA inspections of EPflex Feinwerktechnik GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2024 | NAI | Office of Inspections and Investigations | Postmarket Assurance: Medical Devices |
| February 26, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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