FDA report shows series of lapses at J&J plant

A dozen federal inspections of a Johnson & Johnson factory for nonprescription medicines in the past month show a host of violations that could affect the products.



A new report on the inspections at the Lancaster, Pa., factory indicates a pattern of carelessness in cleaning and maintaining equipment, investigating problems that could affect the makeup of products and maintaining records.



In some cases, medicine batches made during equipment failures were not checked for quality.



Food and Drug Administration investigators had to ask for information many times in some cases, and then wait days to get it.



The agency's report, released Wednesday, comes out as J&J is under scrutiny for eight recalls covering tens of millions of bottles of pain reliever Tylenol and other products.



The report lists 12 different types of violations, from not determining the impact of equipment failures "on the manufacturing process and products" to incomplete records of investigations into "unexplained discrepancies" in manufacturing.



Johnson & Johnson spokeswoman Bonnie Jacobs said the company would not comment specifically on the report.



J&J shares fell $1.58, or 2.7 percent to $57 in late-afternoon trading Wednesday, when the broader markets also were down. Earlier the stock hit a 52-week low of $56.87.



Among other problems cited in the report:



—"Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures to assure that drug products conform to appropriate standards of identity, strength, quality and purity."



—"Deviations from written test procedures are not justified."



—Staff were not following up "to determine the causes for repeated mix-up of tablets."



—Written procedures for cleaning and maintenance did not have enough detail about the methods, equipment and materials to be used.



—The plant did not have drug production and quality control records readily available to the inspectors.



The report covers inspections on 12 consecutive business days, from June 22 through July 9, at the plant, which is operated by a joint venture called Johnson and Johnson/Merck Consumer Pharmaceuticals Co.



The business sells products, including heartburn medicines Mylanta and Pepcid, that originally were sold as prescription drugs and now are available in over-the-counter, lower-dose versions. Merck & Co. of Whitehouse Station, N.J., is J&J's partner in the operation.



On Monday, in response to reports that inspections at the Lancaster factory had found problems — then not publicly disclosed — J&J said it had received the report from the FDA.



A prepared statement said the joint venture "takes the issues raised by the agency seriously and is fully committed to addressing their concerns as rapidly as possible. We will provide a detailed response to the FDA and work diligently to address all observations."