The FDA Investigations Operations Manual includes revised instructions regarding the release of information.
The FDA Investigations Operations Manual includes revised instructions regarding the release of information. It covers the FDAs authority to enter and inspect, inspection notification, detailed inspection procedures (including sampling types and techniques, records and document review) computerized data requests, recall monitoring, inspecting import procedures, federal/state inspection relationships and discussions with management regarding privileged information. It also covers seizure and prosecution, HAACP, bioengineered food, dietary supplements, cosmetics, bioterrorism and product disposition.The manual also includes a directory of Office of Regulatory Affairs offices and visions for all five headquarters and regions and for field monitors.
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