FDA 483 - Arlin D. Wadel - February 11, 2011

This FDA Form 483 document details observations from an inspection concerning record-keeping deficiencies related to pest control and other operational records. The facility failed to maintain records documenting compliance with rodent and other pest control measures, specifically lacking fly control records from July 9, 2010, through January 1, 2011.

Furthermore, a systemic issue with record completeness was identified across multiple record types. Required records, including those for fly and refrigeration, did not contain the signature or initials of the person performing the operation or creating the record. Similarly, all required records, specifically fly, rodent, and refrigeration records, lacked the time of the activity they reflected. Finally, these required records, including fly, rodent, and refrigeration records, did not include the firm's name and the location of the farm. These observations indicate a failure to adhere to good documentation practices essential for demonstrating control over manufacturing and quality processes.