FDA finds manufacturing issues at Impax’s Hayward, Calif., plant
HAYWARD, Calif. — The Food and Drug Administration has found manufacturing issues at a plant owned by generic drug maker Impax Labs, the drug maker said Monday.
Impax said it received a warning letter from the FDA on Tuesday in which the agency said it found “deviations” from current good manufacturing practice, or cGMP, for finished pharmaceutical drugs, related to plant inspections that took place between Dec. 13, 2010 and Jan. 21, 2011. The company said the deviations were found in sampling and testing of in-process materials and drugs, production record review and investigation processes for the failure of certain manufacturing batches to meet specifications. Initial results led to a voluntary recall in March of fenofibrate capsules in the 200-mg strength at the wholesale level; fenofibrate is used to lower cholesterol and triglycerides in the blood.
Impax said the problems only were at the Hayward, Calif., plant.
Annual Dietitian Summit provides insight on role of RDs at retail
CHICAGO — Registered dietitians’ role in retail was emphasized as health-and-wellness professionals from retailers, manufacturers and other organizations gathered for the third annual Dietitian Summit, which was held in Philadelphia last month.
The third annual invitation-only summit — co-hosted by Ahold USA and Field Trip Factory, which unites commerce and other organizations through education — underscored that grocers stress healthy food choices by utilizing RDs, which offer customers the tools to achieve optimal health.
"A key takeaway was the role that trusted grocers play in helping families make healthier choices," Ahold USA health-and-wellness manager Shirley Axe said. "Stores with nutritionists deliver a high return of value because they are the perfect place to deliver relevant health and nutritional information to customers."
The summit also noted that customers experience budget and time constraints. For RDs, this means that they have the opportunity to reach customers but must do so by utilizing encouraging, educational language when touting health benefits while not conveying judgment. This also can be done if grocers increase the use of programs that showcase produce that is presented alongside easy ways to prepare meals.
The summit also found that grocers should try to reach children ages 4 years and older, since teaching healthy eating habits early in life will give way to better eating in the future.
"It’s obvious that RDs at the retail level are firmly embedded and truly reflect a corporate commitment to a store and the community that it serves," Field Trip Factory president and CEO Susan Singer. "By developing programs that teach consumers to quickly and easily prepare meals, RDs have the opportunity to influence both retail sales and the overall well-being of Americans."
Sanofi Pasteur donates tetanus-containing vaccine doses to storm victims
SWIFTWATER, Pa. — The vaccines division of drug maker Sanofi donated vaccine doses on behalf of the Jeff Gordon Children’s Foundation to Direct Relief International, which will aid victims of the recent storms in the Southeast and Midwest.
Sanofi Pasteur announced its donation of 5,500 doses of tetanus-containing vaccine, including 500 doses of Tdap (tetanus, diphtheria and acellular pertussis) vaccine. A tetanus booster vaccine is recommended for adults every 10 years, the drug maker said, noting that there are two forms of tetanus vaccine that predominantly are used in the United States: Tdap, which provides protection against tetanus, diphtheria and pertussis, and Td, which provides tetanus and diphtheria protection.
Jeff Gordon, a four-time NASCAR Cup Series champion, and his wife are the national representatives for the Sounds of Pertussis Campaign, a joint initiative of Sanofi Pasteur and March of Dimes that seeks to educate parents, family members and infant caregivers about the importance of receiving a Tdap booster vaccination. Gordon became involved in the disaster relief efforts after the homes of his engine tuner’s mother and sister were destroyed in Alabama.
"The devastation throughout these regions is astounding," Gordon said. "I’m pleased that the baby products my Foundation is sending to St. Claire County, Ala., and the much-needed Tdap vaccine Sanofi Pasteur is donating to Direct Relief International will assist those who have been affected."