FDA EIR - Freudenberg Medical, LLC - July 22, 2016

An FDA inspection of Freudenberg Medical, LLC, a medical device manufacturer in Carpinteria, CA, was conducted from July 18-22, 2016. The inspection, a QSIT Level I review, identified three main violations of the Quality System Regulation (21 CFR Part 820). First, the firm failed to validate user cleaning methods for its voice prosthesis devices and cleaning brushes, a process critical for device function and patient safety, as required by 21 CFR 820.75(a). Second, design validation procedures were inadequate for the Blom-Singer Adjustable Bi-Flanged Fistula Prosthesis, lacking a required clinical evaluation and failing to identify critical use-related issues during product development, contrary to 21 CFR 820.30(g). Third, complaints, specifically one involving leakage and aspiration pneumonia that led to hospitalization and a Medical Device Report (MDR), were not adequately investigated and were prematurely dismissed as "known and anticipated adverse events," violating 21 CFR 820.198(c). At the conclusion, Vice President & General Manager Dr. Mark H. Ostwald agreed to correct all observations, committing to a written response within 15 business days. Additional issues discussed included improving complaint data analysis and ensuring completeness of complaint forms.