FDA Inspection
Interacoustics A/SInteracoustics A/S – FDA Inspection, Jun 26, 2009
Record Details
This FDA Inspection record concerns Interacoustics A/S, with an inspection on June 26, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Interacoustics A/S
- Inspection Date
- June 26, 2009
- Product Type
- Devices
View Company Profile
ID · 843c93a9-db5b-4536-833d-244fbd15868b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 592357
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.100(a)(1)Analysis of data sources
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(a)(2)Production monitoring and control
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(i)Design changes - validation vs. verification
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)(2)Investigation procedures
- 21 CFR 820.50(a)(1)Documented evaluation
Showing 10 of 11 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Interacoustics A/S
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 10, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Interacoustics A/S
- FDA Inspection 924626 - 2015-04-10
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.