Compliance Resources to Help you Stay Current

The Food & Drug Administration (FDA) notified Cal-Maine Foods, Inc. about their eggs testing positive in a routine study sample for Salmonella Enteritidis (SE). Ohio Fresh Eggs, LLC is one of Cal-Maine Foods’ suppliers. The routine sample test (environmental study) was done on the eggs from this supplier. Ohio Fresh Eggs supplied around 24,000 dozen eggs (unprocessed) to Cal-Maine, who then processed and repacked them at their facility in Arkansas in October 2010. The notification regarding SE presence went to the company only in the second week of November.

Four companies were warned by the U.S. Food and Drug Administration (FDA) about the “unsafe food additive” in the caffeine used in their malt alcoholic beverages. The warning included the threat of seizing their products, a federal law possibility.

The following companies and products are on red alert:

1. Core High Gravity HG, Core High Gravity HG Orange, and Lemon Lime Core Spiked from Charge Beverages Corp
2. Moonshot from New Century Brewing Co., LLC
3. Four Loko from Phusion Projects, LLC (business activities under Drink Four Brewing Co.)
4. Joose and Max from United Brands Company Inc.

The FDA has classified CareFusion’s decision to recall approximately 17,000 Alaris® PC units (model 8015) which had been manufactured or serviced between December 2008 and September 2009 as Class I recall. CareFusion (denoted as CFN in the NYSE) is a leading global medical device company. The FDA classifies the recall of those items as Class I recall when there is substantial possibility that the use or exposure to the product will call serious health hazards or even death.

Del Bueno of Grandview, WA, has issued a recall of all size packages of Queso Fresco Fresh Cheese, Queso Panela Fresh Cheese, Requeson Mexican Style Ricotta Cheese, and Queso Enchilado Dry Cheese as these have been detected to have the potential to be contaminated by Listeria monocytogenes, an organism which can cause serious and at times fatal infections among young children, frail or elderly people, and others with weak immune systems.
 

The Englewood, Colorado-based company said the recall covers those machines which were manufactured and sold before June 2010 and has serial numbers from 001 to 500 and also those from TR1401 to TR 2559.

Infusion pumps are used to deliver fluids -- nutrients and medications such as antibiotics, pain relievers and chemotherapy drugs -- in a controlled manner, and are widely used in hospitals and clinics.

WalkMed detected that the pump door alarms of these devices had the chance of failing to alert the user at the appropriate time, which can potentially cause over-infusion of medication into patients, therefore posing serious health hazards.

The company, however, said that no such accidents have been related till date and the FDA has said in a circular that any untoward incidents may be reported to its MedWatch Adverse Event Reporting program. It must be mentioned here that FDA’s Class I recall which is the highest degree of product recall refers to those products which can pose serious life risk to people.

The Triton Pole Mount Infusion Pump has been distributed to eight customers or distributors all over the country and the company said that five out of them have already been upgraded.

THE LEGAL HURDLE

Title 21 – Food and Drugs of the Code of Federal Regulations (CFR) is the primary regulation for medical devices, which has different sections dealing with various aspects of food, drugs, medical devices, and so on. Among these, 21 CFR 820, the Quality System Regulation, is the most important regulation for medical devises. Violation of this regulation can lead to monetary penalties and seizure of the product being recalled.

RELATED RECALLS

This recall of infusion pumps comes just three weeks after the FDA labeled the recall of CareFusion Corp.'s (NYSE:CFN) Alaris PC infusion units as Class I recall. This recall had covered approximately 17,000 CareFusion infusion units.

In September, Sigma International General Medical Apparatus, LLC similarly recalled its Sigma Spectrum Infusion Pump Model 35700 for reasons similar to the Triton Pole Mount Infusion Pump. In May also, the FDA had ordered Baxter International, a leading manufacturers, to "recall and destroy" all its Colleague brand pumps (approximately 200,000) in the US as the company had failed to ensure quality in spite of repeated notices.

REPORTING DETAILS

Consumers with questions on this product may contact the company directly at 1-303-420-9569 between 8:00 AM and 4:00 PM Mountain Time.

Source:

http://www.scribd.com/doc/37593891/Software-Testing-for-Medical-Devices

A Salmonella scare has led to the recall of Dagoba Organic Chocolate new moon Rich Dark Chocolate 74% cacao 0.32 ounce squares. The Artisan Confectioners Company has announced recall of a limited quantity of its products. Other sizes and other Dagoba items are not covered by the recall. 33 cases of 0.32 oz squares sold across the nation are on recall.

Evidence of Listeria and E. coli contamination at its plant has prompted Bravo Farms of Traver, California, to recall its products. This was announced by Whole Foods Market to whom Bravo supplies the products.  Whole Foods Market sells the products in its stores in Arizona, California, Nevada, Oregon, and Washington.  These are part of the recall since they were cut and packaged in clear plastic wrap and sold with a Distributed by Whole Foods Market sticker.  Signage posted in Whole Foods Market stores conveys the recall to the customers.  Till date no cases of illness have been reported, though.

The products included in the recall are:

• Sage Cheddar
• Silver Mountain Cheddar
• Chipotle Cheddar
• Premium Block Cheddar
• Premium White Chunk Cheddar
• Chipotle Chunk Cheddar
• White Black Wax Cheddar

Consumers who have bought any of the listed products from Whole Foods Market may return them and claim a full refund. 

E. coli O157:H7 gives rise to diarrhea illness, often accompanied by bloody stools. A form of kidney failure can occur in some cases, but most adults recover completely within a week. Young Children and the elderly are more prone to serious complications, leading to even death.

Listeria

Listeriosis is a condition that can be caused by Listeria. It can affect at-risk people like pregnant women, newborns, the elderly and people with weakened immune systems. Symptoms include fever, muscle aches, and sometimes nausea or diarrhea. Symptoms like headache and stiff neck can occur when the infection spreads to the nervous system. Infected pregnant women may experience only a mild flu-like illness.  But infections during pregnancy can result in more serious problems for the fetus.  Immediate medical care should be sought once these symptoms surface. 

Odwalla’s violation of health and safety codes

Violation of health and safety codes can lead to criminal liability. On October 31, 1996 the Food and Drug Administration (FDA) announced that Odwalla would recall its juice products which contained unpasteurized apple juice. The recall resulted from 13 reported cases of E. coli O157:H7 illness which the Seattle-King County Department of Public Health linked to the unpasteurized apple juice.

During the investigation, a genetically indistinguishable strain of E. coli O157:H7 that had been isolated from case-patients was found in a bottle of un-pasteurized Odwalla apple juice.  Further investigation by federal and state agencies was unable to pinpoint the exact source of the E. coli bacteria at Odwalla’s Dinuba, California plant.  But FDA investigators detected numerous violations of health and safety codes at the manufacturing plant, including lack of proper sanitizing procedures and poor employee hygiene.  The plant accepted decayed fruit from suppliers – all clear violations of health and safety codes.  The outbreak left one child dead and over 65 people infected.  It spurred the government to require that all unpasteurized fruit and vegetable juice containers carry a warning label.  In 1998, Odwalla was indicted and held criminally liable.  The company agreed to pay a fine of USD 1.5 million. 

Source:

http://www.fda.gov/Safety/Recalls/ucm234903.htm

http://www.billmarler.com/key_case/odwalla-e-coli-outbreak/
 

Propoxyphene, which is sold under the brand names Darvocet, Darvon, Darvon-N, and Dolene is a narcotic pain-reliever. It is a cough suppressant but is weaker than morphine. Its precise mechanism of action is not known but may involve the stimulation of opioid (narcotic) receptors in the brain. Propoxyphene increases pain tolerance and decreases discomfort but the presence of pain is apparent. Additionally, propoxyphene causes sedation and respiratory depression. The FDA approved propoxyphene in August 1957. An estimated 10 million patients have used propoxyphene-based products since.

Anticipated Troubles Caused by Propoxyphene

New clinical data shows that when propoxyphene is taken at therapeutic doses, there are significant changes to the electrical activity of the heart: prolonged PR interval, widened QRS complex and prolonged QT interval. These changes can increase the risk for serious abnormal heart rhythms. At a press conference, John Jenkins, MD, director of the Office of New Drugs, said the new numbers tipped the risk–benefit ratio against the drug.

The US Food and Drug Administration (FDA) has therefore revoked its approval of the drug and asked Xanodyne Pharmaceuticals to recall it from the US market containing. This decision will also affect generic manufacturers and the makers of Propoxyphene- products.  The latter should also recall their products. FDA has notified healthcare professionals that Xanodyne Pharmaceuticals had agreed to withdraw propoxyphene, with the new data showing that it can cause serious cardiac toxicity, even at therapeutic doses.

Health care professionals have been advised by the FDA to stop prescribing and dispensing propoxyphene-containing products to patients. Further, they have also been requested to contact patients, currently on propoxyphene-containing products and advise them of the risks associated with propoxyphene, and discuss alternative pain management strategies. Patients have been advised to dispose of unused propoxyphene in household trash in line with the Federal Drug Disposal Guidelines.

Propoxyphene gives rise to the following side effects:

• Lightheadedness
• Dizziness
• Sedation
• Nausea
• Vomiting
• Drowsiness,
• Constipation
• Propoxyphene can depress breathing and should be used with caution in elderly, debilitated patients and in patients with serious lung disease.
• It can impair thinking and the physical abilities required for driving or operating machinery.
• Propoxyphene may be habit-forming.

Petitions against Darvon till Date

In June 2008, the consumer interest group Public Citizen filed a federal lawsuit against the U.S. Food and Drug Administration in Washington, D.C. The lawsuit alleged that the agency violated the law by failing to act on a petition it filed in 2006.  The petition sought the withdrawal of Darvocet , Darvon , and generic propoxyphene drugs from the market.  They had been associated with over 2,000 accidental deaths; they were physically addictive and no more effective than other safer painkillers. According to data compiled by the Federal Drug Abuse Warning Network, deaths related to Darvocet, Darvon and other generic propoxyphene drugs accounted for over 5% of all drug-related deaths between 1987 and 2006. In November 2010, four years after the petition was filed, the FDA mandated the withdrawal of Propoxyphene.

Sources:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm234389.htm 

President and CEO of the Advanced Medical Technology Association (AdvaMed), Stephen J. Ubl, released a statement on November 18, 2010, on a new study that evaluates the impact of device regulation on continued medical innovation.

FDA has issued a notification to healthcare professionals - in particular those working in emergency and critical care settings. According to the notification, FDA has received reports to the effect that compatibility problems arise when certain needleless pre-filled glass syringes are used with some needleless intravenous (IV) access systems.

The FDA says in a news release that it will launch a program to promote manufacture of safer and superior external defibrillators. Defibrillators are used to correct heart rhythms. External defibrillators are used thousands of times a year to treat cardiac arrest. Automated external defibrillators (AEDs) are conspicuous in public places. They are even more conspicuous in homes, airports and office buildings. Complex external defibrillators are handled by health care professionals in hospitals. Almost 300,000 Americans suffer cardiac arrest each year. They may die if normal rhythm is not restored promptly. Amongst the many steps taken immediately to revive the patient is the delivery of a high-energy shock from an external defibrillator.

Health professionals and lawmakers have welcomed FDA’s declaration that caffeine is an illegal and unsafe additive to manufactured alcoholic beverages. But critics see in the declaration an infringement of consumer rights.

In recent years, the FDA has come across a number of harmful products marketed as dietary supplements for sexual enhancement. These products actually contain active ingredients present in FDA-approved drugs or variations of these ingredients which have nothing to do with dietary supplements. Sexual enhancement supplements promising rapid or long-lasting effects are likely to contain a contaminant. The FDA has urged consumers who have experienced negative side effects to stay away from such sexual enhancement products and seek help from a health care professional.

The Centers for Disease Control and Prevention (CDC) observes the annual Get Smart About Antibiotics Week from 15-21 November 2010. This is the third annual meeting. The theme for this meet is antibiotic resistance.

New York State Department of Agriculture and Markets Food Inspectors conducted routine sampling of Tuv Taam Salads Nova Lox Salad manufactured by Kosher First LLC. The product was analyzed thereafter and tested positive for Listeria monocytogenes.
According to aFood & Drug Administration (FDA) recall news report,Listeriamonocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frails, or elderly people and others with weakened immune systems. Although healthy persons may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea. Listeria infection can cause miscarriages and stillbirths among pregnant women.

The fresh&easy™ Ginger Spice Cookie Dough (16 oz.) is being voluntarily recalled by the Fresh & Easy Neighborhood Market. This comes with the alert of undeclared peanuts, which could prove a grave risk to those individuals allergic to it, if consumed by them.
The cookies in question were sold in California, Nevada and Arizona in Fresh & Easy Neighborhood Market stores.

The U.S. Food and Drug Administration (FDA) and the University of Rochester have formed a partnership to form the Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION) Initiative.

The FDA has classified CareFusion’s decision to recall approximately 17,000 Alaris® PC units (model 8015) which had been manufactured or serviced between December 2008 and September 2009 as Class I recall. CareFusion (denoted as CFN in the NYSE) is a leading global medical device company. The FDA classifies the recall of those items as Class I recall when there is substantial possibility that the use or exposure to the product will call serious health hazards or even death.

CareFusion, on August 24, 2010, issued an urgent Medical Device Recall Notification to the customers of its Alaris PC unit model 8015. The Notification stated that the affected units may face certain intermittent error in communication under specific wireless network conditions. This would freezes the PC unit screen and finally result in a delay in therapy and the inability in making programming changes to the current infusions. If there is a communication during infusion, the infusion would continue on all channels, as has been programmed originally, but it cannot be modified. Halting the infusion, as a result of this error, to make any modification or changes in programming causes the unit to shut down delaying the therapy. This can cause serious injury or even death.

CarreFusion is still in the process of conducting a corrective action plan to rectify the problems in the hardware of the affected PC units. In the Notification issue, the customers were provided with clinical tip sheets and informed of warning tags for each affected units. Customers were also provided with instructions on the method of temporarily or permanently disabling the wireless mode of the PC unit so as to further allay the risk of serious injury.

Recent Similar Recall

In a recent incident reported in September, the FDA classified another recall of certain makes of AngioSculpt PTCA Scoring Balloon Catheter as Class I recall. This recall applied only to EX catheters — to those with part/REF numbers 2034-XXYY and lot numbers less than F09060003. In December 2009, the manufacturer had informed customers that the PTCA catheters may disintegrate during use and get lodged in the coronary arteries.

Class I, II and III Recalls Described by the FDA

It must be mentioned here that all recalls by manufacturers are categorised by FDA as Class I, Class II or Class III recall based on level of health hazard involved. While in some cases, the manufacturing company itself discovers the snag the product and recalls it from the market, in others, FDA informs the company concerned of its findings on a product and suggests a recall with which the company usually complies. In case the company does not recall, the FDA is authorised to seek legal action under the provisions of the FD&C Act.

The U.S. Food and Drug Administration (FDA) with its mission to promote and protect the health of the people has joined hands with the HHS and has prepared a strategic planning document ensuring provision of safe and nutritious food and improve infrastructure, modernize regulatory processes and strong workforce.

Improving E-health records is needed in order to improve the quality of service and safety of the patients. And to improve the E-health records, the Health IT Policy Committee’s certification workgroup is planning to come up with a new certification course in association with FDA.