# FDA WARNING_LETTER - Interacoustics A/S - June 25, 2009

Source: https://www.keypedia.com/records/warning_letter/interacoustics-as/d2ca7a6c-8601-42d6-9da4-75808c608d88

> FDA WARNING_LETTER for Interacoustics A/S on June 25, 2009. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Interacoustics A/S
- Inspection Date: 2009-06-25
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: An FDA inspection of Interacoustics A/S in Assens, Denmark, from June 22-25, 2009, revealed that their audiometers and diagnostic products are adulterated under 21 U.S.C. 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's September 7, 2009, response to the FDA 483 was deemed inadequate.

Key violations include:
1.  Failure to establish and maintain adequate procedures for finished device acceptance activities (21 CFR 820.80(d)).
2.  Inadequate procedures for corrective and preventive action (CAPA), specifically regarding documenting actions to prevent recurrence of nonconforming product (21 CFR 820.100(a)).
3.  Failure to ensure investigations into the root causes of nonconformities (21 CFR 820.100(a)(2)).
4.  Failure to maintain adequate records of complaint investigations (21 CFR 820.198(e)).
5.  Failure to adequately analyze quality data sources to identify existing and potential causes of nonconforming product (21 CFR 820.100(a)(1)).
6.  Failure to establish and maintain adequate procedures to control non

## Related Officers

- [Director](https://www.keypedia.com/people/timothy-a-ulatowski/23498f67-5e0f-4b28-9039-ad64e2dd5b04)

Company: https://www.keypedia.com/companies/interacoustics-as/570da682-b16b-4d38-9565-0c6d1932c806

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7