Wisconsin firm H&P Industries Inc., accused of making contaminated medical pads and wipes, has closed after U.S. Marshals arrived Monday with orders to seize products.
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Christy Maginn, a spokeswoman for the firm, said the closure was voluntary and that H&P officials are working closely with the U.S. Marshals Service and the federal Food and Drug Administration.
The move comes as FDA officials posted new inspection documents Monday that confirm more contaminated products were found at the Hartland, Wis., company whose recalled alcohol pads and wipes have been cited in lawsuits claiming serious infections and death.
Last week, FDA officials asked H&P officials to voluntarily stop making and distributing drug products.
Two U.S. senators, Michael Bennet, D-Colo., and Lamar Alexander, R-Tenn., last week raised questions about the agency's handling of the recall of hundreds of millions of alcohol prep wipes. They said they became concerned after msnbc.com reports that the FDA knew about problems with contamination and sterilization at the Hartland, Wis., plant nearly two years ago.
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Officials with the FDA, the U.S. Marshals Service and the U.S. Attorneys office in Wisconsin would not confirm or deny the action. The FDA has the power to order seizure of potentially tainted products to protect public health.
Latest inspection reveals more problems
New FDA documents posted Monday reveal problems with additional products manufactured and distributed by H&P and the Triad Group, two firms owned by brothers David Haertle and Eric Haertle of Wisconsin and their sister, Donna Petroff of Antioch, Ill.
Contamination was detected in the firm's antiseptic towlettes and in raw materials used to make over-the-counter fiber products often used as laxatives and to lower cholesterol, inspection reports found.
Contamination of povidone iodine prep wipes with different bacteria, Elizabethkingia meningoseptica, was detected on March 11 and led to an immediate recall of all lots of the product used to prep skin after scrapes and burns and before surgery, the report said.
In addition, inspectors found serious and systemic problems with the firm's "high purity" water system.
"Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance," inspectors wrote.
FDA officials found Triad BZK Towelettes, hygiene products made with the disinfectant Benzalkonium chloride, were contaminated with the bacteria Bacillus cereus, the same organism that led to a world-wide recall of the firm's alcohol prep pads and wipes in early January.
Those wipes have been blamed in at least three lawsuits for serious infections and the death of a 2-year-old boy in Houston.
In the new FDA report, inspectors identified pad material and foil packaging used in the alcohol prep wipes as the potential cause of the contamination, with implications for other products.
"The impact to other products manufactured with the same or similar pad and foil was not assessed," inspectors wrote.
In addition, investigators found that several batches of over-the-counter products failed to remain stable or failed to meet standards for active ingredients. They include hemorrhoidal suppositories and Triad PVP Swabsticks.
H&P Industries products are sold under the Triad Group label and under the private labels of many drugstores and grocery stores, including Walgreens, CVS and Walmart. They are also widely used in hospitals and clinics. For information about specific brands of recalled alcohol wipes, click here. For information about brands of recalled povidone iodine wipes, click here.
Water supply problems
Problems with the plant's water system include failing drains that could allow sewage to back up directly into the system and a "dead leg" in the water supply loop that could cause problems with heat sanitation, according to inspectors. Before March 2009, the firm failed to keep any records of sanitization of the water supply system, they added.
Last week, Michael C. Rogers, the FDA's acting director for the Office of Regional Operations, said that the problems identified in the inspection report, the firm's third in less than a year, prompted the agency to ask H&P Industries to stop manufacture or distribution of all drug products.
H&P Industries officials did not comply until the U.S. Marshals arrived on Monday.
Bennet, the Colorado senator, renewed his call for more oversight.
“Today’s events are a clear sign that the supply chain system for drugs and medical devices is broken," Bennet said in a statement. "The last thing parents should have to worry about is a repeat of this sad situation that put thousands of families at risk, including a Colorado child who developed a life-threatening infection. As FDA reauthorization approaches in Congress, I will continue to fight for stronger oversight for industry, robust quality standards for manufacturers, and greater accountability from the FDA.”
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