Interacoustics A/S – FDA Warning Letter, Jun 25, 2009

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