'Little things' blossomed into big QA trouble at J&J/McNeil

"When they leave, they take the routine with them," said an anonymous former J&J/McNeil worker of QA staff reductions following the company's acquisition of Pfizer Consumer Healthcare in 2006. "It can be a couple of little things that are let go and turn into problems, like machine parts wearing out." An investigation into metal particle contamination of Infants' Tylenol from the company's Fort Washington, PA, plant cited metal-on-metal wear of pistons in bottling-line equipment as the probable source. The plant, voluntarily closed in April 2010 and now under consent decree with the FDA, is undergoing a $100 million remediation. Story

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