Company
GermanyEPflex Feinwerktechnik GmbH, Dettingen An Der Erms, Germany – FDA Inspections
Inspection records and compliance data for EPflex Feinwerktechnik GmbH in Dettingen An Der Erms. 3 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected September 19, 2024.
Company Profile
This profile covers EPflex Feinwerktechnik GmbH based in Dettingen An Der Erms, Germany.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 0
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 1
First inspected June 13, 2013. Last inspected September 19, 2024.
Most cited issue areas
- Nonconforming product, Lack of or inadequate procedures2 inspections
- Design history file1 inspection
- DHR content1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 19, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1249545 |
| February 26, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 921735 |
| June 13, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 839372 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
EPflex Feinwerktechnik GmbH
FEI Number
3003289691
Address
Im Schwollbogen 24, Dettingen An Der Erms, Germany
Country
Germany
ID: 7523fecf-a471-4e7e-925a-d0f40c42be9f