Publicity about substandard or contaminated products usually lights a fire under pharmaceutical companies, which then race to address their compliance problems. But a new US Food and Drug Administration inspection report shows that, despite a stream of product recalls and a Congressional investigation, Johnson & Johnson (J&J, New Brunswick, NJ) has not gotten its house in order yet. And the company’s latest problems conceivably could make things hot for one of its partners.
The inspection report in question contains disturbing observations about J&J’s Lancaster, Pennsylvania, facility, which manufactures over-the-counter products such as Pepcid and Mylanta. If the inspectors’ observations are to be believed, plant managers have been taking a laissez faire approach to the facility’s manufacturing operations. For example, inspectors noted that the plant’s instructions for cleaning and maintaining equipment omitted crucial details about the materials and methods required. Nor did the instructions explain how to disassemble and reassemble equipment to ensure proper cleaning. Inspectors also claimed that the plant’s equipment was not inspected routinely according to written procedures.
This state of affairs opens the door to malfunctions, and FDA officials apparently had a chance to witness several of them. During one packaging operation, a capper machine crashed, a cooling loop failed, and operators observed leaky bottles of product. Yet inspectors said that staff did not conduct quality reviews of products that had been manufactured during equipment failures.
Inspectors did not give the plant’s analytical-testing operations high marks, either. FDA officials said the plant’s laboratory controls did not establish scientifically sound test procedures to ensure that products meet standards of identity, strength, purity, and quality. Inspectors observed as analysts strayed from written test procedures without justification. And when employees took samples of drug products to determine their conformance with specifications, they did not properly identify the samples, according to FDA.
The well-publicized quality problems at its Fort Washington, Pennsylvania, plant apparently haven’t spurred J&J to confirm that its other US manufacturing operations are up to snuff. But the new problems in Lancaster also affect Merck & Co. (Whitehouse Station, NJ), which operates the plant as a joint venture with J&J. I’m sure that Merck does not want its reputation to suffer by association with J&J. If it hasn’t already, Merck will probably lean on its partner to help improve the Lancaster facility. It might take this extra pressure to get J&J to seek and address systemic problems at its manufacturing operations. In the meantime, the public will eye both companies with suspicion.