FDA recall of children's Tylenol, Motrin, Benadryl highlights need for major pharmaceutical companies to use Terahertz inspection in quality control

My note: The following current newstory involves the recall of liquid children's over the counter products. Terahertz inspection, fares worst with liquids, because it can't penetrate most liquid. Hence, terahertz, most likely would not have prevented this problem.
However, please note the description of conditions at the factory, and the absolute lack of QC policies and procedures. One has to surmise that this same problem is present in the production of over the counter pills, and in fact, in January,
the following news was printed in the NEW YORK TIMES:
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In January, the F.D.A. sent a warning letter to McNeil in which officials said the company had failed to thoroughly investigate consumer complaints of a moldy odor from some bottles of Tylenol Arthritis Relief Caplets.

In 2008, a number of consumers reported temporary digestive problems after using the products. But after ruling out bacterial contamination, the company did not initially conduct other testing to determine the root cause of the musty smell, the F.D.A. said.

The warning letter also said that McNeil had failed to alert officials about the problem in a timely fashion — waiting more than a year after the first complaints to notify the agency. A related F.D.A. inspection report cited several other quality control issues, including failure to monitor Tylenol Arthritis Caplets for possible impurities or degradation.
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This is the current story. Perhaps the FDA should mandate the use of Terahertz inspection of all pharmaceutical products.
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NEW YORK (CNNMoney.com) — A scathing report released Tuesday by the Food and Drug Administration slammed conditions at the factory that produced the children’s Tylenol, Motrin, Benadryl and other over-the-counter drugs that were recalled over the weekend.

The 17-page FDA inspection report conducted in late April detailed quality and security lapses at the Fort Washington, PA-based facility, which is owned by Johnson & Johnson’s (JNJ, Fortune 500) McNeil PPC drug manufacturing division. The agency said it is considering a wide range of actions including possible criminal penalties.

Johnson & Johnson said it has temporarily suspended production at the plant. It is the company’s only plant that manufactures all of its liquid pediatric drugs.


The FDA found there were no written procedures to ensure “the identity, strength, quality, and purity” that the drugs produced there were said to possess.

Further, the agency said the plant’s employees “[were] not given training in current good manufacturing practices and written procedures required by current good manufacturing practice regulations.”

McNeil recalled some 50 children’s versions of the non-prescription drugs on Saturday for quality concerns, including “tiny particles” in some of the products that the company said may be solidified product ingredients or manufacturing residue such as tiny metal parts.

The FDA said the recall affects some 1,500 “lots” of the drugs which were distributed both in the United States and internationally.


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