Product: pharmaceutical manufacturing facility
1. Failure to maintain complete and accurate laboratory test data generated in the course of establishing compliance of your APIs to established specifications and standards.
a. There was no written explanation for deletion events observed on audit trails for your standalone HPLC units. Your standard operating procedures (SOPs) did not include instructions for the retention of electronic raw data. In response to this letter, provide your procedures describing requirements to maintain complete data
Audit and identify the extent of this activity in your laboratory and manufacturing operations and provide an update to your investigation into this matter. .
FDA District Office: CDRH