The facility in Lancaster, Pa., is the third Johnson & Johnson plant to be flagged this year by the Food and Drug Administration for serious manufacturing defects — an unusual number for a single company.
The FDA’s latest report was released Wednesday, a day after Johnson & Johnson told investors it had received a subpoena from a grand jury in eastern Pennsylvania. The company is also the subject of a congressional probe into recalls this year of more than 100 million bottles of adult and children’s Tylenol, Motrin, Benadryl and Zyrtec and other over-the-counter medicines.
The company has not recalled any products made in the Lancaster facility, which is a joint venture with Merck. Spokesman Marc Boston said the joint venture “takes the issues raised by the agency seriously and is fully committed to addressing their concerns as rapidly as possible.”
FDA officials who inspected the Lancaster facility from June 22 to July 9 documented 12 deficiencies, including the failure to investigate why some consumers found maximum-strength tablets in regular-strength Pepcid bottles, or mint-flavored tablets in berry-flavor bottles. That kind of error, experts say, suggests both a lapse in the manufacturing process as well as weak quality controls.
Inspectors described with frustration having to repeatedly ask for documents and waiting days to receive what should have been readily available, including things as basic as an organizational chart.
Inspectors found that the plant could not ensure that drugs produced there were up to standard. “Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity,” the inspectors wrote.
They also said the plant failed to follow its own written procedures for cleaning and maintaining equipment.
The FDA inspection took place about a month after a top Johnson & Johnson executive testified on Capitol Hill that the company was working feverishly to address all shortcomings and restore consumer confidence.
In January, the FDA identified problems at a Johnson & Johnson plant in Puerto Rico after the company recalled Tylenol, Motrin and Benadryl products made there. The company said a chemical leached from wooden pallets into the products, imparting a musty odor that later made some consumers ill with temporary gastrointestinal problems.
It was the first of four recalls of Johnson & Johnson products in the past year, including the April 30 recall of 136 million bottles of infant and children’s Tylenol, Motrin, Benadryl and Zyrtec. Those products were recalled after FDA inspectors found widespread manufacturing problems at the Johnson & Johnson facility in Fort Washington, Pa., the only plant where they were being made.
The company has temporarily shut down the Fort Washington plant. In a call with investors Tuesday, Johnson & Johnson executives said that they don’t expect to reopen that plant until mid-2011 and that the company is laying off 300 of the 400 workers based there. The shutdown is expected to cost Johnson & Johnson about $600 million in lost sales this year. The affected products will not be back on store shelves until next year.