Compliance Resources to Help you Stay Current

The use of traditional medicine is widespread. Around the world, a number of people suffering from chronic and terminal illnesses, resort to traditional remedies. Standardized reporting could boost patient safety by identifying traditional treatments.

Lead UN climate negotiator Christiana Figueres has her hands full what with 194 countries breathing down her neck to arrive at a consensus on a climate change treaty at the global warming talks in Cancun.  

Unlike last year in Copenhagen, she was holding forth on leveraging value chains – a phrase one would associate with supply chain management.  She implored to the 200 business leaders in attendance at the World Climate Summit to transform the sector they operate in.  The latter may oblige in the backdrop of climate action stagnating at Cancun and Congress.  Companies are dealing with the supply chain climate problems on their own. They are collaborating and open-sourcing with their peers beyond all expectations. Quicker, cheaper and larger-scale solutions are thus emerging.

The Penumbra System Reperfusion Catheter 032 was marketed as a device used to re-establish blood supply to the brain, in patients experiencing stroke. However, the device maker Penumbra, after consultation with the FDA, issued a class I recall on their Reperfusion Catheters 032, belonging to lot F15020.

Tacoma-based Pacific Functional Fluids LLC., has been fined USD 21,000 by the U.S. Environmental Protection Agency (EPA), to settle hazardous chemical reporting violations. The company stores and distributes petroleum and other products at its facility.

The SEC is the regulator of the US capital market. When investors purchase municipal securities, the issuer parks the proceeds in reinvestment products until such time as they are required. Bank of America Securities (BAS) was recently censured by the SEC for rigging bids.

This article describes the background and regulatory violations that led this SEC action.

The cans of chicken salad bear the establishment number "P-169" inside the USDA mark of inspection and the lot code "0225XXQBC". The U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) re-issued Recall Release RC-064-2010, upon receipt of additional information from the recalling firm to correct the "Best-by" date so consumers can confirm they no longer possess the recalled products. This is a Class II recall where there is a health hazard situation with a remote probability of adverse health consequences from the use of the product.
 

Service Energy LLC, headquartered in Dover, Delaware, was fined USD 40,000 by the U.S. Environmental Protection Agency (EPA), for violation of oil spill prevention regulations at its two oil storage facilities located at Lewes and Sussex. The settlement penalty took into account the company’s financial position, the co-operation it extended to EPA and its eventual compliance with EPA regulations.

Two separate natural health products (NHPs) are being recalled from the Canadian market. These products, Probiophilus and Cultures de Yogourt 5 Milliards, labeled non-dairy, are being voluntarily recalled by Les Importations Herbasanté Inc. and Bio-Dis Inc respectively.

The U.S. Environmental Protection Agency ordered the owner of an abandoned factory, Hillcrest Building, located in the Scranton area, to comply with asbestos cleanup regulations. The Pennsylvania Department of Environmental Protection conducted two inspections and issued two notices of violation to Walter Stocki, for violating asbestos regulations. EPA conducted a follow-up inspection and confirmed that the property was still contaminated with asbestos.

The Enterprise Knowledge Platform (EKP) from NetDimensions has updated a new version 6.3 of its learning management system. NetDimensions is a global provider of performance, knowledge, and learning management systems. The primary products developed by the company are the Enterprise Knowledge Platform (EKP), the Enterprise Assessment Platform (EAP) and the Enterprise Content Platform (ECP).

Industry veterans joined Green Automotive Company Corporation to facilitate the company’s endeavor towards vehicle compliance and certification to ensure it conforms to standards as they gear up for its U.S. sales of the Zotye Electric SUV. Green Automotive Company is a U.S. public company and the exclusive importer/distributor of Zotye Electric Cars/SUVs to North America.

In 1992, the Energy Star program was introduced in an attempt to promote energy efficient products. Though the initially labeled products were computers and monitors, the program now includes a broad range of items, from appliances to commercial buildings. The focus of this program is to promote energy conservation and generate awareness among consumers.

The U.S. Department of Energy (DOE) joined the Renewable Energy and Energy Efficiency Export Initiative, supported by seven other U.S. Government agencies. The initiative is a coordinated effort to promote renewable energy and energy efficiency exports.

For decades now, doctors and health care providers have been eagerly awaiting safe and efficient weight-loss therapies. Numerous drugs have been launched so far and rejected by the FDA as they failed to meet the agency's criteria. Qnexa from Vivus Inc., and lorcaserin from Arena Pharmaceuticals Inc., are among the list of drugs that failed to gain FDA approval in recent times. Drug trials linked these drugs to potential heart problems, birth defects and cancerous tumors. Earlier this year, Meridia weight loss pill from the Abbott Laboratories stable was also recalled from the market after regulators said it increased the risk of heart attack and stroke.

Lobby Shoppes, Inc. has recalled three of its products, Gourmet Cheese Popcorn (12 oz. bags and 24 oz. bags), Chicago Triple Mix Popcorn (12 oz. bags) and Caramel Corn (2 ½ lb. bags, 4 lb. bags, and 9 oz. tubs) because they contained undeclared ingredients like milk and soy, which can trigger serious allergies in susceptible individuals.

The FDA has issued a warning letter to Align Technology Inc., a company that makes a popular teeth straightener, the Invisalign system, on its failure to report information about patient side effects. The warning letter accused the company of failing to comply with FDA requirements to report serious side effects associated with medical devices. It cited some patient complaints about allergic reactions to the Invisalign trays such as swollen lips and mouth ulcers.

McNeil Consumer Healthcare, a division of McNEIL-PPC, Inc., has initiated, in consultation with the FDA, a recall of one product lot of ROLAIDS® Extra Strength Softchews, Cherry Flavor, 36 count package, distributed in the United States.

Nike has announced the release of a public version of its Environmental Apparel Design Tool. The tool was built over seven years at a cost of USD 6 million. The eco-friendly design tool gives each design an overall score allowing designers to make informed decisions and effect design changes in the earliest stages of production thereby minimizing wastage.

On November 29 a report was released by the President’s Council of Advisors on Science and Technology (PCSAT). Called Accelerating the Pace of Change in Energy Technologies through an Integrated Federal Energy Policy, the report furnishes a roadmap for the federal role to transform the energy system within a decade or two. The PCAST has sought regular strategic Quadrennial Reviews of energy policy on the lines of quadrennial reviews brought out regularly by the U.S. Department of Defense.

The first one is scheduled for early 2015. The group is comprised of presidentially appointed experts from varied fields. The fields represented are academia, nongovernmental organizations and industry. The group suggests a DOE level version of the review by June 1, 2011, focusing on DOE’s activities. According to the authors, the following factors justify the federal plan:

McNeil Consumer Health care, Division of McNeil –PPC, Inc., in consultation with the U.S Food and Drug Administration (FDA) has recalled certain products. This is a voluntary recall of the following products:

All product lots of Children's BENADRYL® Allergy FASTMELT® Tablets (in Cherry and Grape Flavors) distributed in the United States, Belize, Barbados, Canada, Puerto Rico, St. Martin, and St. Thomas.