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FDA Cites Quality Control Problems at Third Johnson & Johnson Plant

By Paul Napoli

July 24, 2010

A U.S. Food and Drug Administration (FDA) inspection has found quality control problems at a third Johnson & Johnson manufacturing facility.

Federal officials inspecting the J&J plant in Lancaster, PA, documented problems with the company's manufacturing practices, including sloppy recordkeeping, failure to clean and maintain equipment and lack of an established laboratory standard to ensure drug quality, reports The Washington Post.

"Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity," the FDA said.

The investigation also revealed that the company neglected to follow up on consumer complaints of the wrong product in packages and ineffective products.

An article by the Associated Press lists other violations in the FDA's report, including:

• Procedures to prevent "objectionable microorganisms" from getting into medicines appear not to have been followed.

• "Deviations from written test procedures are not justified."

• 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.

The Lancaster facility, a joint venture between Johnson & Johnson and Merck Consumer Pharmaceuticals, produces heartburn and gas relief medications such as Pepcid, Imodium and Mylanta.

The two other manufacturing facilities the FDA cited for violations were in Las Piedras, Puerto Rico and Fort Washington, PA, with the Fort Washington plant closed until 2011 to correct the problems. Violations prompted recalls of millions of products manufactured at both facilities. The company has not issued a recall at this time of any products made at the Lancaster, PA facility in association with the FDA inspection.

Originally posted at InjuryBoard by Paul Napoli

Full post as published by New York City Personal Injury Lawyer on July 25, 2010 (boomark / email).