The monitoring procedures listed in you plan include "Visual observation" of
"Time ofthe first bin exits from cold storage." We would like confirmation that
your reference to "cold storage" is a freezer (typically maintained in the
neighborhood of minus 18 °C) and not some other type of refrigeration type of
storage (e.g., maintained at::; 4.4 °C) which could affect the effectiveness ofthe
12-hour critical limit control.