J&J halts production at Pennsylvania after FDA QC criticism

A Food and Drug Administration (FDA) inspection​ of the Fort Washington facility last month found that, among other observations, raw materials used for the production of J&J’s Tylenol range were contaminated.

Specifically the FDA said that those in charge of quality control at the plant “did not adhere to [good manufacturing practice] GMP regulations​” because “no quality notification was implemented regarding the rejection of [the] contaminated lots​.”

In addition, the agency said the firm had failed to monitor “the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.”​

The FDA also criticised J&J for failing to take corrective and preventative action about 46 consumer complaints it received “regarding foreign materials” found in products made at the plant

Agency compliance director Deborah Autor told the Wall Street Journal​ that: "The findings are serious, but we cannot say yet whether further action by the FDA is warranted."​

In response McNeil Consumer Healthcare, the J&J unit that operates the Fort Washington plant, initiated the recall of more than 40 products, including, in addition to Tylenol, Motrin, Zyrtec and Benadryl.

McNeil said that: “The quality issues that the FDA has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us.​

“We have temporarily suspended production at our Fort Washington, PA plant, where the observations were made. We will not restart operations until we have taken the necessary corrective actions and can assure the quality of products made there.​"

J&J will hope that these corrective actions can be completed as rapidly as possible, particularly in terms of its lucrative Tylenol range was already the subject of a major recall​.