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Boehringer Laboratories Gets 483 on Design Validation Lapses

April 20, 2012
Design validation deficiencies at Boehringer Laboratories’ Phoenixville, Pa., plant have landed the company an FDA Form 483. A review of quality records on production procedures for suction regulators and other parts used in the Engenex wound therapy system uncovered several issues, the Nov. 7, 2011, form states.
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