Source:
Washington PostFederal officials who inspected a Johnson & Johnson manufacturing plant that makes Mylanta, Pepcid and other popular heartburn medicines unearthed quality control problems, chaotic recordkeeping and complaints by consumers that medicines were either ineffective or contained pills from different products in the same retail package. 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, Zyrtec and other popular over-the-counter medicines. The company has not recalled any products made in the Lancaster facility, which is a joint venture with Merck...
FDA officials who inspected the Lancaster facility from June 22 to July 9 documented 12 deficiencies, including the failure of the company to investigate why some consumers found maximum-strength tablets in regular-strength Pepcid bottles, or mint-flavored tablets in berry-flavor bottles. Experts say that kind of error 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.
Federal inspectors found that the Lancaster 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...
Read more:
http://www.washingtonpost.com/wp-dyn/content/article/2010/07/22/AR2010072206169.html