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Violations found at J&J drug factory

Associated Press / July 22, 2010

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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 made during equipment failures was 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 J&J is under scrutiny for eight recalls since September covering tens of millions of bottles of Tylenol and other popular nonprescription medicines.

The report lists 12 different types of violations including not determining the impact of equipment failures “on the manufacturing process and products.’’

Johnson & Johnson spokeswoman Bonnie Jacobs 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.’’