I have not been a part of the audit during the the FDA or BSI visits. However, I have been called during the visit regarding the documents that I have written. Their main objective was to clear out the inconsistencies in the reports. The documentation meets the defined quality objective of the organizations The activities performed are in conformity with the documented system. The quality system is effective with respect to documentation and its implementation, in meeting the defined quality objectives, and statutory and safety requirements are being fulfilled.