FDA Finds Quality Control Problems At Another Johnson & Johnson Plant

Federal drug inspectors have found problems with yet another Johnson and Johnson drug manufacturing plant, this time located in Lancaster, Pennsylvania. 

The drug maker confirmed reports this week that it received a report from the FDA that indicates there are deficiencies at the plant, which is a joint venture between Johnson & Johnson and Merck Consumer Pharmaceuticals. Pepcid is one of the products manufactured at the plant.

The FDA report, known as a Form 483, is not yet available to the public because it contains sensitive industry information that needs to be redacted before it can be released. Neither Johnson and Johnson nor Merck have released any details about the deficiencies found at the plant.

The inspection report comes after Johnson & Johnson has issued a number of recalls as a result of problems with quality control at other plants, particularly through its McNeil Healthcare subsidiary.

On April 30, a recall was announced for nearly 40 liquid children’s medications made by McNeil Consumer Healthcare, including infant Tylenol, Benadryl, and Motrin. The products were recalled due to particulate contamination and irregularities in potency. As a result of the problems, the FDA issued a warning letter about quality control issues at the Johnson & Johnson manufacturing plant in Ft. Washington, Pennsylvania.

The recall affected 136 million bottles of children’s medications, resulting in the shutdown of the plant and the suspension of production of all of McNeil’s children medications. Following that recall, the FDA has received nearly 800 complaints, including at least seven reports of deaths associated with the medication. However, the FDA says its investigations so far have not directly linked any of the recalled products to any of the deaths.

In addition, the company has issued a series of Johnson and Johnson drug recalls for a variety of drugs due to chemical contamination from wood pallets that give the drug a musty smell and have caused a number of people to fall ill. The problem is due to contamination by trace amounts of a chemical called 2,4,6-tribromoanisole, or TBA, which seeped into bottles from wood pallets treated with pesticide. The contaminated drugs had a moldy smell and made some users sick.