483
Corden Pharma Fribourg SACorden Pharma Fribourg SA – FDA 483, Feb 3, 2023
Record Details
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.
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ID · 3a01de4a-ae1d-4a69-97a4-e83db8b94ead
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