date:Jun 10, 2014
egulations.
The company responded in January, describing corrections to the agencys observations, but FDA issued another letter because it stated that AMK had not made adequate corrections.
Significant violations that FDA indicated persist include failure to:
Provide information on scheduled processes, including the processing method, type of retort or other thermal processing equipment employed, minimum initial temperatures, times and temperatures of processing, sterilizing value, or other e