Sage told the FDA in its response to a Form 483 that corrective and preventive action (CAPA) standard operating procedures (SOP) had been updated to assess whether the CAPA would affect validated machine settings or its sampling plan, the agency says.
The FDA deemed the response inadequate because it failed to address the actual investigations of the nonconformities, according to the letter. The company did not review and evaluate the process for or perform revalidation of the deviations, the letter says. For example, Sage changed a process parameter for a welder used in its production line for the catheters but did not revalidate it before implementing the change. See letter at http://www.fda.gov/foi/warning_letters/s7095c.htm
The GMP Letter