FDA WARNING_LETTER - VBM Medizintechnik GmbH - June 10, 2010

On June 7-10, 2010, an FDA inspection of VBM Medizintechnik GmbH in Sulz Am Neckar, Germany, revealed that their QuickTrach Sterile Tracheostomy devices, Jet Ventilation Catheters (JVC), and Control Inflator Devices were adulterated under 21 U.S.C. 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Design Control Deficiencies (21 CFR 820.30):** Failure to document design validation (820.30(g)) and verification (820.30(f)) results in the design history file for the QuickTrach II. Inadequate procedures for design change validation/verification (820.30(i)), exemplified by an unvalidated talcum coating change for Control Monitors. Also, design review procedures lacked requirements for independent review (820.30(e)). 2. **Corrective and Preventive Action (CAPA) Issues (21 CFR 820.100):** Failure to verify/validate CAPA effectiveness (820.100(a)(4)) and adequately document CAPA activities/results (820.100(b)). 3. **Complaint Handling (2