The incoming chairman of the U.S. congressional committee investigating Johnson & Johnson’s recalls of consumer products Friday identified the previously unnamed third-party manufacturer behind last week’s Rolaids recall.
Rep. Darrell Issa of California, in a letter to Food and Drug Administration Commissioner Margaret Hamburg, said investigations by his staff revealed North Carolina-based Best Sweet as the company contracted by J&J to produce widely used Rolaids antacid products.
In the letter, Issa, the ranking Republican on the House Committee on Oversight and Reform, questions the FDA’s relationship with J&J’s McNeil consumer products unit.
It asks whether the agency was informed that Best Sweet was the third-party manufacturer of Rolaids and whether the FDA is doing enough to assure McNeil’s compliance with current good manufacturing practices standards.
“Since Best Sweet’s facility produces more than 4 billion products each year, I am concerned about the FDA’s knowledge of Best Sweet’s contractual relationship with Johnson & Johnson in manufacturing Rolaids and whether or not the FDA is acting appropriately to determine if there are other similar public safety concerns about products manufactured by Best Sweet,” Issa said in his letter to Hamburg.
Best Sweet makes pharmaceuticals, consumer health care products, candy and food, said Issa, who will chair the committee when Republicans take control of the House next year.
J&J last week recalled all batches of Softchews Rolaids after consumers reported finding wood and metal bits in them. J&J, which recalled some 130 lots of the product, said at the time that problems were uncovered with a third-party manufacturer it did not name.
The Issa letter asks the FDA to provide answers to a series of questions no later than Jan. 5, including whether J&J identified Best Sweet as the third-party manufacturer to the FDA.
The congressman also asked the FDA to provide any dates and reasons for inspections of Best Sweet as well as copies of inspection reports or warning letters issued by the FDA to the manufacturer.
FDA spokesman Christopher Kelly said the agency would respond directly to Issa.
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