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

Source: https://www.keypedia.com/records/eir/freudenberg-medical-llc/56d27678-f2a7-4251-98e2-75ccb14bb24c

> FDA EIR for Freudenberg Medical, LLC on July 22, 2016. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Freudenberg Medical, LLC
- Inspection Date: 2016-07-22
- Product Type: devices
- Office Name: Los Angeles District Office
- Summary: 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.

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Company: https://www.keypedia.com/companies/freudenberg-medical-llc/ef21cdf9-4cc6-4f08-aad5-c26dcb1b2a36

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b