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Storz Gets Warning for Failures in Handling of Defective Devices

November 4, 2010
Storz Medical has received an FDA warning letter for GMP failures in its handling of defective devices. Storz’ Tagerwilen, Switzerland, facility had no protocol, including acceptance criteria, for a change implemented to fix cracked cooling pumps in its Modulith SLX-F2, a urological stone therapy device, according to the letter. A March inspection also found Storz did not follow its procedure for control of nonconforming products. It had no documentation of the evaluation and disposition of certain pumps with cracked intakes. The defect was spotted during production.
The GMP Letter