Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.

The primary remit of healthcare providers with regard to fire safety is the protection of patients, visitors and health service staff from the effects of fire. For the application of effective fire precautions in healthcare premises, healthcare organisations will need to select a combination of measures to produce a fire-safe design, taking the following points into account: 1. all statutes and guidance relevant to the scheme as a whole; 2. this manual and other associated Firecode manuals; 3. the advice and approval of local building control and fire and rescue authorities; 4. the advice of healthcare staff (estates staff, healthcare fire safety managers and advisers etc). This manual is an important component of the Firecode suite. It covers a range of general fire safety measures that apply throughout healthcare premises and should be read in conjunction with other manuals in the Firecode suite.