Pepcid factory problems mirror Tylenol mess

By Parija Kavilanz, senior writer

NEW YORK ( -- Another Johnson & Johnson manufacturing plant -- this one making heartburn and gas relief drugs Pepcid, Imodium and Mylanta -- was cited for a pattern of quality lapses similar to those seen at the company's shuttered Tylenol plant.

Earlier this month, safety inspectors from the Food and Drug Administration issued a "Form 483" to Johnson & Johnson's Lancaster, Pa., plant.

A Form 483 is issued after an FDA inspection finds problems with a company's manufacturing practices.

The Lancaster plant is owned by Johnson & Johnson-Merck Consumer Pharmaceuticals, a joint venture of J&J and Merck (MRK, Fortune 500), but is operated by the company's McNeil division.

McNeil, which makes pain and cold drugs such as Tylenol and Motrin, is under investigation by the FDA and lawmakers in connection with successive recalls of those drugs over the past year. McNeil shut its plant in Fort Washington following a scathing FDA inspection report of the factory in May that cited 20 manufacturing violations.

This latest setback for Johnson & Johnson is raising questions about lax quality standards at its over-the-counter drug factories and the possibilty of a pattern that could result in the FDA hitting the company with another warning letter or tougher oversight at its plants.

Disturbing pattern

The latest inspection report on the Lancaster plant, released by the FDA on Wednesday, cites 12 violations of good manufacturing processes, at least five of which were also observed at the Fort Washington plant.

One expert said the violations observed at the Lancaster plant are "very serious."

"If this is going on in Johnson & Johnson plants that make over-the-counter drugs, is this indicative of what is going on in other parts of the company's business?" said David Rosen, who worked at the FDA for 14 years. Rosen is now with with law firm Foley & Lardner and advises major pharmanceutical companies on FDA regulations and compliance.

In an conference call with analysts this week, Johnson & Johnson's chief financial officer Dominic Caruso declined to comment on whether other company plants had received Form 483 reports.

At both plants, inspectors questioned whether lab procedures and controls were adequate to assure products "conform to appropriate standards of strength, quality and purity."

Both plants were cited for failing to properly review an unexplained manufacturing discrepancy in a batch of drugs and for not properly following up on consumer complaints about products made at the facilities.

Specifically, the FDA's report on the Lancaster plant noted that the staff failed to follow up on several consumer complaints, including instances where consumers said they found mint-flavored Pepcid tablets mixed inside the same bottle as berry-flavored tablets. There were also multiple complaints about a product lot for "lack of effect."

Experts said "lack of effect" could mean that the product was not producing the desired result when used. The FDA report did not name the product. Also, inspectors said the plant's complaint coordinator did not initiate an investigation of the product.

However, the report did not mention the possibility or need for a product recall.

Additionally, regulators said the Lancaster factory didn't properly document equipment malfunctions or keep adequate maintenance records. Inspectors said they found unlabeled test tubes filled with product sitting out on a counter. The factory also didn't properly clean utensils used in the drug making process.

One industry expert, who did not want to be named, said he would not be surprised if the FDA is pondering further action on the Lancaster plant, such as a warning letter or a consent decree. Under a consent decree, the plant would be able to continue production, but would have constant third-party inspection.

The FDA and Johnson & Johnson declined to comment on the possibility of further enforcement action against the company. To top of page

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