Enforcement Report

Notification and Public Warning Class I recalls almost always warrant a press release to the media. Classes II and III are not necessarily announced in the media, but all of them are included in the FDA s weekly enforcement report, posted at www.fda.gov/opacom/Enforce.html on the FDA s website. 

Source UNODC Annual Reports Questionnaires data, National Household Surveys submitted to UNODC, United States Department of State (Bureau for International Narcotics and Law Enforcement Affairs) International Narcotics Control Strategy Report law enforcement reports, reports from epidemiological networks, UNODC Global Assessment Programme on Drug Abuse (GAP)... 

Bundeskriminalamt (SKA) and other Law Enforcement Reports, UNODC Global Assessment Programme on Drug Abuse (GAP) international Narcotics control strategy Report,... 

FDA Enforcement Report Index. 1990-. Weekly. URL http // www.fda.gov/opacom/Enforce.html. This database provides access to drug and medical device recalls and product seizures in the United States. A search form incorporated into the opening page enables keyword searches of the entire collection. Simple queries involving only one factor, such as a company or brand name, quickly locate pertinent recall notices, each of which identifies specific product batches, quantities withdrawn from commerce, and their previous geographic distribution. Each entry also describes the reason for recall (contamination,... 

One of the more powerful deterrents that the U.S. FDA uses is adverse publicity. The U.S. FDA has no authority to require a company to advertise adverse publicity, but it does publish administrative actions against a company in any number of federai publications, such as the Federal Register, FDA Enforcement Report, FDA Medical Bulletin, and FDA Consumer (35). 

Methamphetamine availability has increased sharply over the past year in the Northeast Region, primarily because of an increase in wholesale distribution by Mexican criminal groups. .. National-level laboratory seizure data as well as law enforcement reporting indicated that domestic methamphetamine production has expanded to more areas of the country. .. Law enforcement reporting and drug seizure data indicated that methamphetamine production has increased sharply in Mexico since... 

Law enforcement reporting indicates that heroin remains readily available throughout most major metropolitan areas, and availability is increasing in many suburban and rural areas... Estimates ofworldwide heroin production increased considerably between 2001 and 2002 primarily because of increases in Afghanistan—a primary source of heroin destined for Europe. Heroin production estimates for Colombia and Mexico decreased, however. ... 

It is the responsibility of a pharmacist to know what products have been recalled. All recalls are published in the FDA Enforcement Report Index as soon as information about the recall is available. This report is available online at <[Pg.54]

FDA Enforcement Reports Index. U.S. Food and Drug Administration Web site. www.fda.gov/opacom/Enforce.html. Accessed December 15, 2006. 

The Bureau of Ocean Energy Management, Regulation and Enforcement, Report regarding the Oauses of the April 20, 2010 Macondo Well Blowout (14 September 2011). 

Baseline Amounts — The following is a list of baseUne amounts or ranges for probable violations frequently cited in enforcement reports referred for action. 

Maisel analyzed the weekly FDA Enforcement Reports issued between January 1990 and December 2000. They reported their assessment of 52 advisories involving 408,500 pacemakers and 114,645 ICDs. Hardware malfunctions and computer errors accounted for 95% of device recalls. This included about 1.3 milhon device checks and analyses and involved 36,187 device replacements at an approximate cost of 870 million (186). 

Table 20.7 Food and drug administration enforcement report definitions.

I The detailed enforcement reports compiled from the Analysis Information Online website can prove to be an invaluable tool for the transportation professional. Most safety managers know their major weaknesses as they relate to safety comphance. By reviewing the reports provided, safety managers can see how their peers are performing, areas enforcement may be focusing, and problem areas for the industry or a region. Objectively use this data as selection criteria for areas to self-audit at your motor carrier. You may want to ask yourself, How are we doing with that ... 

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