FDA Report Outlines Problems at Johnson & Johnson PA Plant

A new federal inspection report details failures and deficiencies at a Johnson & Johnson drug production plant where operations have been suspended for nearly a year following a massive string of drug recalls. 

The FDA released inspection reports this week, detailing the findings of investigators who have been working to categorize problems at a plant in Fort Washington, Pennsylvania, operated by McNeil Consumer Healthcare, a Johnson & Johnson subsidiary. The inspectors found a number of problems at the facility that included poor quality control measures, and inadequate and sometimes disjointed tracking and responses to consumer complaints.

The Fort Washington plant was shut down earlier this year following a massive drug recall on April 30, which affected 40 different liquid medication products, including Tylenol, Benadryl and Motrin. The recall affected 136 million bottles of children’s medications and problems at the plant resulted in the suspension of production of all children’s medications made by McNeil for much of 2010.

The plant was initially shut down after investigators found bacteria in the raw materials used to make over-the-counter drugs, but inspectors have continued to go back to the facility to look for problems and signs of improvement. The latest report covers a period from September until December 9 of this year.

Most of the problems cited in the report revolve around the failure of the factory to follow up on investigations into problems with certain drugs to adequately discover why the problems existed and to ensure that adverse events were not repeated. The investigators also found problems with how the factory tracked and followed up on consumer complaints. Much of the report, however, is redacted to protect trade secrets and names.

The report on the Fort Washington plant follows a similar inspection report on Johnson & Johnson’s Puerto Rico facility, the only plant the company has left for the manufacture of over-the-counter drugs. Inspectors who investigated that facility found similar quality control deficiencies.

The ongoing problems with Johnson & Johnson, which have resulted in a string of recalls throughout the year, have resulted in Congressional hearings and have increased the likelihood that the FDA will receive increased powers to regulate drug makers.