New FDA report shows multiple lapses at J&J plant

July 21, 2010 2:44:06 PM PDT
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 show a pattern of carelessness in cleaning and maintaining equipment, investigating problems 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 Lancaster plant is operated by J&J in a joint venture with Merck Consumer Pharmaceuticals. It produces OTC products such as Pepcid and Mylanta.

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

During a conference call with financial analysts yesterday, Johnson and Johnson disclosed that the company has received a grand jury subpoena from the US Attorney's office in Philadelphia, in connection with a federal investigation into the recalls of several popular children's medications.

During the call, the company disclosed that the recalls and the shut-down of a Fort Washington, PA production plant are expected to slash about $600 million out of its 2010 sales of over-the-counter products.

Late last week, Johnson and Johnson, and McNeil Consumer Healthcare sent the FDA an action plan for dealing with its manufacturing issues. As part of the plan, 300 to 400 people at the Fort Washington plant are being laid off, while the company modernizes it.

The company reiterated that the medications made at the plant would be unavailable at least through the end of this year ? but said it was making efforts to shift some of the production of those medicines to other plants.