Third Johnson & Johnson Plant Under Investigation

By Mike Holter

Medication pills (LEGAFI) -- Federal investigators have uncovered more issues at yet another Johnson & Johnson plant. The plant in Lancaster, Pennsylvania is the third Johnson & Johnson plant to be flagged by the Food and Drug Administration this year for serious manufacturing defects and quality control issues, a number they say is unusually high for a single company.

The Lancaster plant -- which produces the popular heartburn medications Mylanta, Pepcid and others -- was cited by federal officials for quality control problems and chaotic record keeping. The investigation was launched after officials received numerous complaints from consumers that the medications were either ineffective or not in the properly marked bottles. The Lancaster investigation comes amidst a recall of 136 million bottles of adult and children’s Tylenol, Motrin, Benadryl, Zyrtec and other over-the-counter medicines launched earlier this year, and three other recalls of Johnson & Johnson products within the last year. No recall has been issued yet for medicines manufactured at the Lancaster plant, but FDA investigators say Johnson & Johnson could not ensure that drugs produced there were up to standard.

FDA inspectors found 12 deficiencies at the Lancaster Johnson & Johnson plant, including failure to investigate why some consumers found pills from different products in their bottles, such as berry-flavored Pepcid tablets mixed in with mint-flavored Pepcid tablets. The error suggests both weak quality controls and a lapse in the manufacturing process. Official also noted the plant was unable to produce basic documents such as an organizational chart and failed to follow its own written procedures for cleaning and maintaining equipment.

Johnson & Johnson has had to grapple with quality control lapses at two of its plants in Puerto Rico and Fort Washington, Pennsylvania, forcing it to recall tens of millions of bottles of popular consumer medicines. Numerous consumers became sick from a musty odor found in products produced at the Puerto Rico plant, which was caused by a chemical leaching from wooden pallets into the products. The Fort Washington plant has been shutdown until mid-2011, and is expected to cost Johnson & Johnson nearly $600 million in lost sales this year.

On top of the financial losses caused by the recalled products, Johnson & Johnson is likely to face legal battles from yet-to-be-filed consumer class action lawsuits.