FDA WARNING_LETTER - Bauer & Hasselbarth Gmbh - September 16, 2010

An FDA inspection of Bauer & Haselbarth - Chirurg - Gmbh in Ellerau, Germany, from September 13-16, 2010, revealed that the firm's Tracheal Tubes, and Vaginal & Rectal Specula devices are adulterated and misbranded. The adulteration stems from non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), while misbranding relates to failures in Medical Device Reporting (MDR) (21 CFR Part 803). Key QS violations include inadequate process validation (21 CFR 820.75(a)), insufficient corrective and preventive action (CAPA) procedures for analyzing quality data and preventing recurrence (21 CFR 820.100(a)(1), 820.100(a)(3)), uncontrolled production processes (21 CFR 820.70(a)), inadequate control of nonconforming product (21 CFR 820.90(a)), deficient finished device acceptance procedures (21 CFR 820.80(d)), incomplete device history records (21 CFR 820.184), and quality audits not conducted by independent personnel (21 CFR 820.22). The firm's response to the audit independence issue was deemed adequate. Additionally, the firm failed to develop and implement written MDR procedures (21 CFR 803.17). The FDA deemed most of the firm's September 29, 2010, response inadequate, lacking evidence of implementation or sufficient detail. The firm is required to provide a written response within fifteen working days detailing corrective actions, preventative measures, and a timeline for completion, with documentation and translations. Failure to correct these serious violations will result in refusal of admission for devices into the U.S., impact federal contracts, halt Class III premarket approvals, and prevent the granting of Certificates to Foreign Governments.