FDA sets legal standards for shuttered J&J plant

The consumer health-care unit of Johnson & Johnson will be barred from resuming operations at its Fort Washington manufacturing plant until it meets quality standards.

The drug maker entered into a legal agreement Thursday with the Food and Drug Administration that requires the company to retain independent experts to monitor efforts to fix manufacturing problems at the plant, and destroy the drugs that have been recalled.

Howard Sklamberg, director of enforcement with the FDA office of regulatory affairs, said there is no date set for when the changes must be made.

“Fortunately, the firm has very much of an incentive to reopen the facility as quickly as possible,” Sklamberg said. “So the firm, we would think, would be working with us to put the facility in a position where it could reopen.”

The Fort Washington plant closed in April after manufacturing defects led to large recalls of Tylenol, Motrin, Zyrtex and Benadryl.

A representative of McNeil Consumer Healthcare, the division of J&J involved, said the company does not plan to reopen the facility this year. In a statement, the company said the agreement is in line with remediation efforts already in place.

Plants in Lancaster, Pa., and Puerto Rico that have failed to meet federal standards in the past were not closed, but they will operate under strict federal oversight for at least five years.