Home » Boehringer Laboratories Gets 483 on Design Validation Lapses
Boehringer Laboratories Gets 483 on Design Validation Lapses
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.
The GMP Letter
The GMP Letter
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