{"id":581110,"date":"2010-05-27T08:22:16","date_gmt":"2010-05-27T12:22:16","guid":{"rendered":"http:\/\/www.sevensidedcube.net\/?p=13482"},"modified":"2010-05-27T08:22:16","modified_gmt":"2010-05-27T12:22:16","slug":"fda-criticized-johnson-johnson%e2%80%99s-tylenol-plant","status":"publish","type":"post","link":"https:\/\/mereja.media\/index\/581110","title":{"rendered":"FDA criticized Johnson & Johnson\u2019s Tylenol plant"},"content":{"rendered":"

\"FDAAn incisive report issued Tuesday by the FDA <\/strong>(Food and Drug Administration)\u00a0harshly criticizing the conditions of the plant where Johnson & Johnson<\/strong> produce Tylenol<\/strong>, Motrin, Benadryl and other drugs that were withdrawn from the market for\u00a0the weekend.<\/p>\n

The inspection report conducted by the FDA<\/strong> in late April, detailing the flaws in quality control and safety of the plant located in Fort Washington, Pennsylvania, owned by the McNeil <\/strong>division of Johnson & Johnson<\/strong>.\u00a0The agency said it was considering several actions, including possible criminal penalties.<\/p>\n

For his part, Johnson & Johnson<\/strong> has temporarily suspended production at the plant, the only company that manufactures all of its liquid drugs for pediatric use.<\/p>\n

“Nothing worries us more than give parents the products of the highest quality for their children. The quality problems that detected the FDA<\/strong>, many of which we identified in our own inspections and had informed the FDA<\/strong>, are unacceptable” the company said Tuesday.<\/p>\n

Meanwhile, the regulatory agency asked the parents to discontinue use of any of the recalled products, and warned that if they used them the possibility of a negative medical effect was “remote.”<\/p>\n

Deborah Author, director of the Office of Certification Standards of the FDA<\/strong>, said the agency had met in February with the directors of Johnson & Johnson<\/strong>.\u00a0”We express serious concerns about McNeil <\/strong>manufacturing operations ” he said, although the routine inspection of the plant was already scheduled, the meeting accelerated the process.<\/p>\n

Deborah\u00a0Author also admonished McNeil <\/strong>because this is the fourth recall in the past seven months.\u00a0”It’s another example of the severe consequences a company faces when it takes full responsibility for the quality of their medicines,” he said.<\/p>\n

The FDA <\/strong>will conduct a more detailed analysis of the report before determining the effects that McNeil <\/strong>will assume.\u00a0Author said the measures could range from a warning notification to criminal penalties.<\/p>\n

The report also noted that McNeil <\/strong>did not take “corrective and preventive measures” after receiving 46 consumer complaints between June 2009 and April 2010, which reported the presence of foreign material and dark spots on the medicines.<\/p>\n

The plant also followed the rules of quality control and laboratory facilities. McNeil <\/strong>purchased contaminated raw material containing a type of bacteria which is not identified yet.<\/p>\n

The regulatory agency found no written protocols to ensure “the identity, strength, quality and purity” of the produced drugs.\u00a0He also reported that plant employees “received no training on manufacturing practices, or procedures in writing as required by regulations for good manufacturing practices.”<\/p>\n

On Saturday, McNeil <\/strong>recalled 50 versions of their drugs for children (sold without prescription), the FDA said the recall affects 1,500 batches of drugs, distributed in the United States and worldwide.<\/p>\n

Related posts:<\/p>\n

    \n
  1. Tylenol Recall 2010 by McNeil Consumer Healthcare<\/a><\/li>\n
  2. McNeil and Johnson & Johnson under investigation<\/a><\/li>\n
  3. McNeil Promises Quality Repair<\/a><\/li>\n<\/ol>\n

    <\/p>\n","protected":false},"excerpt":{"rendered":"

    An incisive report issued Tuesday by the FDA (Food and Drug Administration)\u00a0harshly criticizing the conditions of the plant where Johnson & Johnson produce Tylenol, Motrin, Benadryl and other drugs that were withdrawn from the market for\u00a0the weekend. The inspection report conducted by the FDA in late April, detailing the flaws in quality control and safety […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-581110","post","type-post","status-publish","format-standard","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/581110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/comments?post=581110"}],"version-history":[{"count":0,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/581110\/revisions"}],"wp:attachment":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/media?parent=581110"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/categories?post=581110"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/tags?post=581110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}