FDA update – April 5 2011

Medical wipes-maker in Hartland, Wisc. stops production

Wisconsin maker of recalled alcohol wipes shut down on Monday, following the arrival of U.S. Marshals, after failure to comply with U.S. Food and Drug Administration request to close voluntarily.

H&P Industries, which makes alcohol wipes and other products distributed by Triad Group, has been under investigation by the Food and Drug Administration for bacterial contamination issues. Triad Group has been sued by a Texas couple who blame the firm for the death of their 2-year-old son.

In the lawsuit, filed in federal court in Houston, Shanoop and Sandra Kothari say an alcohol wipe from the company was the likely source of bacterial meningitis that killed their son, Harry, in November. Last week, the FDA asked H&P Industries to voluntarily stop production of its drug products.

Did Triad have to have the US Marshall’s enter their facilities and seizure all their products and basically close down their operations?

As you can see it is rare for the FDA and U.S. Marshals to seize materials at a medical products plant.

In 2010, there were 10 seizures in the food, drugs and medical-device industries, 3,799 product recalls, and 673 warning letters, according to the FDA.

FDA inspection reports have revealed numerous issues at the H&P plant, including employees packing acne pads into product containers with their bare hands and children's multi-symptom cold medicine made without a necessary active ingredient; equipment and utensils not cleaned, maintained and sanitized at appropriate levels to prevent contamination that would alter the safety, identity, strength, quality or purity of a drug product.

A previous 30-page inspection report, dated Nov. 29, documented numerous issues at the plant, including a bucket labeled as "purified water" that was actually deionized water used to rinse equipment after cleaning. A rubber neoprene wheel that had debris on it touched every medical prep pad. The bars on which prep-pad material passed under had debris built up on them. Also, there was microbial contamination of water pipes leading to vats that made batches of mouth rinse and glycerin suppositories

The latest inspection report noted that H&P had not done enough to investigate contamination problems, including the recall of iodine prep pads due to bacteria found in sample results reported on March 11.

H&P investigated the source of bacteria contamination of sterile and non-sterile alcohol prep pads and found that pad material and foil were identified as potential contamination sources. But the impact to other products manufactured with the same or similar pad and foil was not assessed, according to the inspectors.

The company failed to keep adequate records for the sanitizing of equipment, the inspection report notes. The company also lacked written guidance for the maintenance of air filters and its air system in an environmentally controlled room, according to the inspection report.

With all these problems, Triad could have decided to work with the FDA and impose a voluntary shutdown to prevent a mass seizure of the products and basically forcing a shutdown. In these rare cases, we find that working with the Agency and coming to a hard but forthcoming decision to protect the public is the way to deal with the FDA and the situation. It is also the best way to assure that you get back into business again in the shortest time. The next step in this situation is for the FDA to usually go for a permanent injunction and get a consent decree from Triad. It will be the company’s decision on how they want to proceed.

Any questions on this new Industry update please email us at info@mdiconsultants.com and Ref: Triad