Truckloads of medical products, tankers of bulk liquids and cartons of chemicals have been hauled to secure landfills and waste disposal centers as a Wisconsin supplier works to recover from a year-long contamination scandal blamed for illness and death.
By one account, H&P Industries and the Triad Group of Hartland, Wis., had enough potentially tainted medical prep wipes to fill a football field.
The sister firms have either destroyed or reconditioned more than $6 million of suspect products seized by federal regulators last spring, bringing them in compliance with a court order, new government documents show.
The firm’s $4 million penal bond has been canceled and the seized products have been returned to H&P’s jurisdiction for disposal, possible steps toward reopening, according to new Food and Drug Administration documents obtained through an msnbc.com open records request and appeal.
The discarded products included 50 truckloads of finished goods, 13 truckloads of raw chemicals and five bulk tank-trailers of in-process materials, according to Shelly Burgess, an FDA spokeswoman.
"The firm will not be permitted to resume operations until FDA is satisfied that it can do so with full compliance with the decree and the law," Burgess said.
It took H&P Industries three tries to gain FDA approval of a reconditioning plan that outlines an overhaul of manufacturing, monitoring, inspection and reporting procedures to correct problems with contamination and sterilization. Previous plans were not detailed enough to satisfy FDA’s concerns, the documents posted online late Tuesday showed.
“Because of both micro- and cross-contamination concerns, FDA has no [good manufacturing process] assurance and is uncomfortable with introducing any potential risk back into the market,” said Tamara Ely, an FDA compliance officer, according to an account of a November 21, 2011 meeting.
Only unopened, factory-sealed raw chemicals will be allowed to be “reconditioned” so that they’re safe for use either by H&P Industries or by a vendor who agrees to accept returned product, the documents showed. The reconditioning procedure requires sampling, testing and approval to verify that no microbial contamination exists.
Everything else — finished products, in-process products, materials in tanks and drums, raw chemicals, bulk chemicals and other open, used components — was destroyed. The firm is still prohibited from manufacturing drugs or devices, Burgess noted.
H&P’s compliance comes more than a year after FDA officials urged the company to issue the first of several global recalls of alcohol and iodine prep products potentially contaminated with at least two kinds of bacteria because of inadequate manufacturing and sterilization procedures.
FDA officials had known for years about problems with the Wisconsin plant, but had failed to adequately enforce regulations, an msnbc.com investigation found.
The move also comes nearly a year after parents of a 2-year-old Houston boy first filed a lawsuit claiming that contaminated alcohol pads made by H&P Industries were responsible for the bacterial infection that killed their son.
Since then, at least a dozen lawsuits have been filed by patients and their families in several states who claim that tainted prep wipes led to infections, illnesses and, in some cases, deaths.
H&P Industries officials did not respond to msnbc.com requests for comment, but the firm consistently has denied that its products could be directly tied to those events.
Burgess, the FDA spokeswoman, confirmed the number of truckloads of finished medical products, tanker trucks of bulk liquids and containers of chemicals that the company was forced to destroy.
But by another estimate, the volume of returned alcohol and iodine prep products alone would have filled an area “the size of a football field,” according to a lawyer representing the Triad Group.
“There are billions of these pads produced a year, millions in a day, believe it or not, so it is massive what has been returned,” lawyer Alana Bassin told U.S. District Court Judge Lynn Hughes during a July briefing, a court transcript shows.
The medical products have been transferred to secure landfill and destruction sites that operate under regulatory jurisdiction. Some of the material may have to be processed as hazardous waste, the documents noted.
H&P Industries' plans for the future remain unclear. The firm’s 285,000-square-foot plant at 700 W. North Shore Drive , Hartland, Wis., is for sale for $14.2 million, real estate listings show.