“Significant Violations” Still Found By FDA At Johnson & Johnson Manufacturing Plant - Newsome | Melton Law
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The Wall Street Journal reports that the U.S. Food and Drug Administration again cited the pharmaceutical manufacturer, Johnson & Johnson. This time, the FDA found that during an inspection of a Puerto Rico manufacturing plant, the drug maker had “various deficiencies.”

This inspection took place between September and early November, with FDA officials finding “that J&J failed to follow written quality-control procedures, didn’t properly investigate manufacturing snafus, released into the market drug products that should have been rejected for quality violations,” as well as committing several other violations, according to the Wall Street Journal.

This latest setback comes on the heels of the drug manufacturer attempting to “recover from a series of medicine recalls due to quality problems,” the site reports.

The Journal explains this company “has been plagued by a series of product-quality problems, mainly at its McNeil Consumer Healthcare unit, which makes over-the-counter medicines. The company has recalled Tylenol, Motrin, Benadryl and other products for problems ranging from musty odors that caused nausea in consumers, to excessive concentrations of active ingredients.”

The site reports that the manufacturer has already closed its Fort Washington, Pa., plant to “undergo a refitting to address manufacturing problems there,” which is costing the company “hundreds of millions of dollars in lost sales and facility upgrades, not to mention potential liability stemming from suits filed in connection with the recalls.”

The Wall Street Journal reports that the “Justice Department is conducting a criminal probe of issues related to the recalls.” The article goes on to explain that although Johnson & Johnson has made progress overcoming recent events by getting small supplies of its children’s liquid Tylenol to stores, “another round of recalls announced the past two weeks, together with the new FDA inspection report, show it will be no easy task for J&J to convince government authorities and consumers that its products are top-notch.”

This latest setback involves a Las Piedras, Puerto Rico plant, which manufactured some of the recalled products. The news source reports that the FDA previously issued a warning in January, explaining it found “‘significant violations’ of manufacturing rules at the plant that resulted in faulty products. Consumers had complained of musty or moldy odors in products made at the facility, which J&J eventually traced to a chemical used on wooden pallets to transport packaging materials.”

This recent inspection exposed continued issues at that plant. The Wall Street Journal reports that according to a recent report from the FDA, “J&J has received consumer reports of product mix-ups, in which one drug is found in a container for another product. In July, plant workers found Motrin inside a Tylenol container.”

The news source reports “J&J said it has provided a detailed response to the FDA and will work to address these most recent observations.” Nevertheless, The Wall Street Journal reports that “procedures at the Las Piedras plant may not be sufficient to prevent future product mix-ups,” according to the FDA.   

If you or a loved one has experienced serious side effects or health complications with a Johnson & Johnson product, contact Newsome Law Firm  and fill out a case evaluation form today. Our team of attorneys has experience specific to complications associated with hazardous medication. Not only can they give you the legal guidance you need, they can help you get the compensation you deserve.


Loftus, Peter. (November 28, 2010) “J&J Suffers Another Manufacturing Blow.” Retrieved on December 2, 2010 from The Wall Street Journal.