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Tylenol Maker Cited for Issues at Puerto Rico Plant – Again

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For the second time this year, a drug making facility operated by Johnson & Johnson’s McNeil Consumer Healthcare unit in Puerto Rico has been cited by the US Food & Drug Administration (FDA) for quality issues. According to a report in The New York Times, it does not appear that McNeil has yet fixed many issues cited in a warning letter the agency issued last January.

The Puerto Rico plant made millions of bottles of Tylenol, Motrin and other products that were recalled at the beginning of this year.

According to the Times, an inspection report just posted on the FDA website echoes many of the quality issues mentioned in the January letter. These include: distribution of drugs that failed quality requirements, a failure to identify product defects during routine testing, failure to detect incorrect expiration dates on drug labels, failure to adequately investigate product problems, failure to follow laboratory controls and inadequate training of lab staff.

“Clearly, this inspection shows that the company continues to have serious quality control issues at its plant and that it is not in compliance with current good manufacturing practices required by federal law,” an FDA spokesperson told the Times.

McNeil says it has responded to the FDA’s latest concerns and that it has been working hard to improve its manufacturing processes.

This has been a tough year for Johnson & Johnson. Since January, it has issued more than a half-dozen withdrawals of Tylenol and other over-the-counter medicines, contact lenses and certain hip-replacement parts, according to a Wall Street Journal report.

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