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According To Fda Report, J&j Plant Still Has Quality Control Issues

December 17, 2010

According To FDA Report, J&J Plant Still Has Quality Control Issues

According to a Daily Finance news story released yesterday, regulators revealed that Johnson & Johnson “still hasn’t solved all the problems at the Pennsylvania plant largely responsible for a huge recall of children’s medicine earlier this year.”

The article goes on to explain that “More than 135 million bottles of different over-the-counter medicines were recalled in late April because of manufacturing deficiencies at J&J’s McNeil Consumer Healthcare Unit plant in Fort Washington, Pa.” According to the article, this most recent Food and Drug Administration inspection revealed “horrific conditions and processes, including such findings as grime, dust, a hole in the ceiling and bacteria-contaminated raw ingredients.”

The article goes on to explain that since April, plant operations have been suspended as “J&J conducted a full review of its manufacturing processes.” However, the Daily Finance reports that “according to FDA investigators, a recent inspection conducted from Oct. 27 through Dec. 9 still revealed problems, most notably, a failure to properly follow customer complaints.”

According to the article, a recent inspection report released by the FDA found numerous additional problems with the plant. The Daily Finance reports these include such procedural issues as failure to establish “Control procedures that monitor the output and validate the performance of the manufacturing processes,” “failure to thoroughly review any unexplained discrepancy and failure of a batch or any of its components,” as well as a lack of record keeping to “allow data to be reviewed at least annually to evaluate the quality standards.”

The news source further reports “a discrepancy and a failure of a batch or any of its components did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.” Finally, the article reports the FDA found that the company failed to always make records of “unexplained discrepancies” and didn’t always follow “responsibilities and procedures applicable to the quality control.” 

The news source states that since the initial April recall, J&J has “issued many other recalls, some resulting from its review process, but not all.” The Daily Finance explains that a Puerto Rico plant “also tied to the drug recalls reportedly still has quality control problems as well.” The Daily Finance claims that additional recalls “are likely as the review process continues.”

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.

References:

Alazraki, Melly. (December 16, 2010) “FDA Finds More Problems at Johnson & Johnson Plant.” Retrieved on December 17, 2010 from Daily Finance.
 

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