FDA WARNING_LETTER - Cochlear Bone Anchored Solutions AB - May 17, 2007

On May 14-17, 2007, an FDA inspection of Cochlear Bone Anchored Solutions AB in Goteborg, Sweden, identified significant Quality System (QS) and Medical Device Reporting (MDR) deficiencies for their Baha Systems Bone Conducting Hearing Aids, Baha Intenso, Baha Divino, and Baha Cordelle II system. These devices were deemed adulterated under 21 U.S.C. 351(h) and misbranded under 21 U.S.C. 352(t)(2).

Key violations include: 1. **Failure to evaluate complaints for MDR reporting (21 CFR 820.198(a)(3)):** The firm's procedures did not ensure timely MDR submissions (within 30 days) and lacked clarity on classifying issues like speech processor failures or infections. Training documentation for personnel evaluating complaints was also absent. 2. **Failure to document rework and reevaluation (21 CFR 820.90(b)(2)):** Rework activities were not documented in the Device History Record (DHR). (Response deemed adequate). 3. **Failure to verify device design with established acceptance criteria (21 CFR 820.30(f)):** Acceptance criteria were not set before verification. (Response noted, future inspection to verify). 4. **Failure to