Washington, DCA third Johnson & Johnson (J&J) manufacturing plant, this one located in Lancaster, PA, has been flagged by federal officials as result of a recent inspection. The problems reportedly include poor quality control, chaotic recordkeeping and different products in one retail package, such as maximum strength Pepcid tablets in regular strength bottles. Furthermore, the plant reportedly failed to follow its own cleaning and maintenance protocols.
J&J runs the plant as part of a joint venture with Merck.
FDA officials inspected the Lancaster facility from June 22 to July 9 and documented 12 deficiencies, including a failure to investigate consumer complaints. The inspectors themselves experienced problems, in that they had to repeatedly ask for documentation that took days to arrive, when the information should have been readily available.
According the Washington Post, the inspectors wrote, "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 problems at the Lancaster plant follow earlier troubles reported at J&J's Puerto Rico plant, which resulted from a massive recall of children's medications issued earlier this year.