New FDA report shows multiple lapses in procedures at Johnson & Johnson plant in Pennsylvania

New FDA report shows multiple lapses at J&J plant

TRENTON, N.J. — A dozen recent federal inspections of a Johnson & Johnson factory for heartburn and other nonprescription medicines show a host of violations that could affect the quality and makeup of the drugs.

A new report on inspections at the Lancaster, Pa., factory in the past month indicates a pattern of ignoring rules for manufacturing and quality, failure to investigate problems that could affect the composition of products, carelessness in cleaning and maintaining equipment, and shoddy record-keeping.

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 comes out as New Brunswick, N.J.-based J&J is under scrutiny for eight recalls since September covering tens of millions of bottles of pain reliever Tylenol and other popular nonprescription medicines.

The inspection report, released Wednesday, 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. The latter problem occurs “whether or not the batch has already been distributed,” the report states.

Johnson & Johnson spokeswoman Bonnie Jacobs would not comment on most of the report. But she said in a statement, “McNeil Consumer Healthcare responded as quickly as possible to the needs of the FDA during the inspections, and provided a large volume of material to the agency.”

Jacobs also would not discuss personnel at the plant. The inspection report lists Richard S. Norris as the plant manager. In a telephone call with The Associated Press, he said he could not discuss the report either but confirmed that he is still the manager.

FDA spokeswoman Elaine Gansz Bobo said the agency is still working on its final report on the Lancaster plant.

“There has been no determination as to next steps or further action at this time,” she said.

J&J shares fell $1.46, or 2.5 percent, to $57.12 in trading Wednesday, when the broader markets also fell. Earlier the stock hit a 52-week low of $56.87.

The recalls, which included children’s medicines, involved products made at a Fort Washington, Pa., factory shut down in April — and expected to remain closed for another year while it is upgraded — and at a factory in Las Piedras, Puerto Rico.

The shutdown and the recalls, estimated to cost $600 million this year, led Johnson & Johnson to sharply reduce its 2010 profit forecast. Analysts and other experts are calling for the ouster of top management. The manager of the Fort Washington plant has been fired, and 300 of the 400 workers there will lose their jobs.

Among the 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.”

—Procedures to prevent “objectionable microorganisms” from getting into medicines appear not to have been followed.

—”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 recent drug production and quality control records readily available to the inspectors, as is required.

—Samples of drug products taken to determine if they met written specifications were not properly identified.

—There was no preventive maintenance program for at least five types of complex manufacturing or testing equipment.

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 diarrhea treatment Imodium and heartburn medicines Mylanta and Pepcid, that originally were sold as prescription drugs and now are available in over-the-counter 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 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.”