Transonic CAPAs Noted in FDA Form 483
Ithaca, N.Y.-based Transonic received an FDA Form 483 after an inspection revealed several CAPA shortfalls.
For example, the company initiated a CAPA in response to customer feedback about leakage with AV loops but failed to capture all lots affected by the problem, according to the March 21 form. The CAPA was closed in March 2012, but there was a subsequent complaint related to broken tubing, the agency notes.
Another CAPA was initiated when COSTATUS monitors were bringing up a message saying “turn off then turn on,” but would not proceed further even after restarting. Transonic did not document its investigation activities that led to corrective actions, the FDA says.
Meanwhile, complaint records lacked complete documentation of investigation activities, and do not document whether corrective action is required.
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