Another Johnson & Johnson drug plant gets flagged

By Parija Kavilanz, senior writer


NEW YORK (CNNMoney.com) -- Johnson & Johnson, already under fire from the government over deplorable conditions at a Pennsylvania plant that makes children's pain and cold drugs, is now being cited for problems at another one of its drugmaking plants in the state.

A plant located in Lancaster, Pa., was recently inspected by the Food and Drug Administration and failed to receive a clean bill of health, according to the company.

The Lancaster facility received what is called a "Form 483." A Form 483 is issued after an FDA inspection yields unsatisfactory results for compliance with regulations or a violation of good manufacturing practices.

The FDA regional office in Philadelphia did not return calls seeking details about the observations made in the report. However, Johnson & Johnson confirmed that the company has received it.

The facility is a operated by Johnson & Johnson-Merck Consumer Pharmaceuticals, a joint venture of J&J (JNJ, Fortune 500) and drugmaker Merck (MRK, Fortune 500) formed to develop and market over-the-counter drugs derived from Merck's prescription medicines. The unit makes non-prescription products such as heartburn relievers Mylanta and Pepcid and multi-symptom relief drug Imodium.

"JJ/MCP takes the issues raised by the agency seriously and is fully committed to addressing their concerns as rapidly as possible," the companies said in a statement. "We will provide a detailed response to the FDA and work diligently to address all observations."

Experts in FDA regulatory compliance said companies tend to take Form 483 reports seriously. If a company does not adequately address the deficiencies cited in a report, the FDA can issue another one or escalate its response to a warning letter. Failure to correct violations can result in fines or even tougher measures by the FDA.

For example, a plant in Fort Washington, Pa., run by J&J's drug making unit McNeil Consumer Healthcare, received Form 483 reports prior to its shutdown in early May, the same month that McNeil recalled about 135 million bottles of children's and infant's Motrin, Tylenol and other drugs made at the plant. (See correction, below)

McNeil has begun an overhaul of that facility to bring it into FDA compliance.

Also, the FDA issued a warning letter earlier in January to McNeil citing manufacturing violations at its plant in Puerto Rico, after McNeil issued a recall of several over-the-counter drugs made at the plant including Tylenol, Motrin and Benadryl following complaints of an "unusual moldy, musty or mildew-like" odor.

Late Thursday, McNeil announced a mass layoff of hundreds of workers at the Fort Washington plant, where all production has been suspended after the FDA cited multiple safety and quality violations there.

Given the intense scrutiny on Johnson & Johnson and its McNeil division, one expert said a new Form 483 issued on another of the company's factories doesn't bode well.

"It shows that there is a systemic issue at the company and management has to do a better job in bringing the facilities into compliance with FDA regulations," said Bill Kurani, founder of Antrix Inc., a regulatory affairs & quality assurance consulting firm.

Correction: CNNMoney incorrectly reported that the FDA issued a warning letter to McNeil for its Fort Washington, PA. plant. The warning letter was sent to its plant in Puerto Rico. To top of page

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