Federal officials recently inspected a Johnson & Johnson plant in Lancaster, Pennsylvania that manufactures Mylanta, Pepcid, and other heartburn medicines. Simply put, the officials were less than happy with what they found. The plant seemed to have a complete lack of organization and fell far below standards. In fact, according to recent reports, inspectors documented twelve deficiencies.
One of the shortcomings of the facility is that they failed to investigate customer complaints, such as why maximum-strength caplets were found in regular strength bottles and mint-flavored tablets were mixed in with berry-flavored bottles. Certainly such a mistake would be shocking to a customer who places their health in the hands of the company and trusts in the quality of their product. Investigators were frustrated to find that the plant failed to follow its own policies for cleaning and maintaining equipment. They also were shocked by how difficult it was to obtain standard documents, such as a basic organizational chart. Ultimately, the "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."
Johnson & Johnson has faced a slew of scrutiny in the past several months, causing a plant in Fort Washington, Pennsylvania to be shut down and a Congressional probe opened due to recalls of Children’s Tylenol and Motrin. The plant will re-open in mid-2011 after firing three-fourths of the workers and loosing around $600 million in sales. Johnson & Johnson’s drastic action reveals their dedication to eradicating quality control issues. However, the Lancaster plant is the third location flagged by the Food & Drug Administration this year, so hopefully the company will continue to work hard to solve each and every issue that emerges. Until then, however, this is indeed a scary set of facts.