www.fdanews.com/articles/156703-transonic-capas-noted-in-fda-form-483
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
The GMP Letter