Prescription for Harm

Prescription for Harm PDF

Author: Henry A. Waxman

Publisher:

Published: 2007-09

Total Pages: 20

ISBN-13: 9781422315880

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The Food & Drug Admin. (FDA) was created 100 years ago to protect the public from dangerous food & drugs. Enforcement actions against purveyors of contaminated or unsafe products played a central role in the agency¿s effectiveness. This report examines how the Bush Admin. has carried out the FDA¿s historic enforcement responsibilities. It is the result of a 15-month investigation that included a review of thousands of pages of internal agency enforcement records. The report finds that there has been a precipitous drop in FDA enforcement actions over the last 5 years. In some cases, FDA headquarters rejected the enforcement recommend. of FDA field offices despite findings by inspectors that violations led to multiple deaths or serious injuries.

FDA Investigations Operations Manual

FDA Investigations Operations Manual PDF

Author: Food and Drug Administration

Publisher:

Published: 2003

Total Pages: 0

ISBN-13: 9780865879737

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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.

Hard to Swallow

Hard to Swallow PDF

Author:

Publisher:

Published: 1989

Total Pages: 32

ISBN-13:

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Abstract: This report prepared by the House Subcommittee on Oversight and Investigations describes a series of resource problems, program and management deficiencies, and ineffective coordination with the U.S. Customs Service which have reduced the ability of the FDA to assure the quality and safety of imported food.