483
Lonza Bend Inc.Lonza Bend Inc. – FDA 483, Aug 5, 2022
Record Details
An FDA inspection of Bend Research, Inc. in Bend, OR, a contract manufacturer, revealed significant deficiencies in their quality system regarding investigations of unexplained discrepancies. The firm failed to extend investigations to all affected batches and frequently closed investigations without definitive root causes or corrective actions. These issues could result in the distribution of non-conforming drug products.
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ID · 8b51d03e-655e-4357-92ad-22a1fd139bff
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