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Transonic CAPAs Noted in FDA Form 483

June 28, 2013
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 GMP Letter