For any medical device manufacturer an FDA audit is a necessary and a potentially difficult part. The company should maintains proper documentation . The updated documents like DHF,DMR and dozens of other demonstrates the commitment to quality , accuracy and thoroughness. When the work is properly logged and updated documents one could easily fulfill the auditor’s request for any documents or work record because the faster the auditor gets satisfies the better impression he will have about the business. In order to pass FDA audit it is important to organize the procedure, documents and data in clear, logical order. BY going through the documents and work record the FDA inspector will know that company follows the GMP, the staff is knowledgeable and familiar with regulations and GMP, the documents demonstrates the training, monitoring and compliance program. Records should be maintained in a way that is usable and easily accessible.