FDA 483 - Corden Pharma Fribourg SA - February 03, 2023

An FDA inspection of Corden Pharma Fribourg SA, a pharmaceutical manufacturer in Villars-sur-Glane, Switzerland, revealed significant deficiencies in their quality control processes. The firm failed to thoroughly investigate out-of-specification results and unexplained discrepancies, and their annual product reviews lacked adequate discussion of significant product variability. These issues indicate a need for improved quality system oversight.