Inspector/manufacturer communication encouraged as part of FDA compliance "culture change".
This article was originally published in The Gray Sheet
Executive Summary
FDA INVESTIGATOR/MANUFACTURER DISCUSSION OF ADVERSE FINDINGS DURING INSPECTIONS is being encouraged by the agency, FDA Deputy Commissioner for Regulatory Affairs Gary Dykstra said Sept. 20 during a "Compliance Video Conference" sponsored by FDA and the Food and Drug Law Institute. FDA is emphasizing to its field inspectors that they should "discuss things more openly with the firm as they are doing their investigation."