I do not have any personal experience with FDA audits. But i feel its always wise to adhere to the Good Clinical Practices(GCP) to stay on the safer side. Sticking to the proper Standard Operating Procedures(SOP) to maintain the consistency, or proper documentation of the data, receipts, subject consent forms and records keeps one in compliance with FDA. Correcting any unexpected deviation from the protocol, prompt and complete reporting of adverse events and good record keeping are some of the preventive measures followed by the every manufacturing company to gain the approval from FDA.