FDA Finds MDR, CGMP Violations at German and Czech Medical Device Facilities
The Food and Drug Administration informed two medical device companies of violations of Medical Device Reporting and current good manufacturing practice regulations, in two warning letters dated March 1. According to FDA, inspections at Linet’s Slany, Czech Republic, facility (here)…
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and VE Valley Electronics’ Murnau Am Staffelsee facility (here) revealed the violations. Each firm’s initial response was inadequate, FDA said. Both firms have 15 days from the date of receipt of the each respective letter to respond with corrections.