Company
DenmarkInteracoustics A/S, Middelfart, Denmark – FDA Inspections
Inspection records and compliance data for Interacoustics A/S in Middelfart. 2 FDA inspections on record (1 OAI), last inspected April 10, 2015.
Company Profile
This profile covers Interacoustics A/S based in Middelfart, Denmark.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected June 26, 2009. Last inspected April 10, 2015.
Most cited issue areas
- Analysis of data sources1 inspection
- Design changes - validation vs. verification1 inspection
- Design validation - software validation not performed1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 10, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 924626 |
| June 26, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 592357 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Interacoustics A/S
FEI Number
3000254565
Address
Audiometer Alle 1, Middelfart, Denmark
Country
Denmark
ID: 555f8645-591d-4b03-965d-044c72229554