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Congress to probe McNeil's GMP violations

Published on 07/05/10 at 08:30am

The US Food and Drug Administration may take additional regulatory action against Johnson & Johnson subsidiary McNeil Consumer Healthcare over its quality control problems, according to new information published on its website.

And adding to the pressure on the company, it emerges that the US Congress is also planning to launch its own investigation into the recall of more than 40 over-the-counter medicines for children, including liquid formulations of Tylenol (acetaminophen), the antihistamine Zyrtec (cetirizine), cough medicine Benadryl (diphenhydramine) and painkiller Motrin (ibuprofen).

The probe, by US Representatives Ed Towns (Democrat-New York) and Darrell Issa (Republican - California), is also questioning the adequacy of FDA's inspection procedures.

McNeil announced the recall a few days ago after an FDA inspection uncovered serious issues at the plant, including bacterial contamination, and temporarily suspended production at the plant in Fort Washington, Philadelphia.

In a lengthy post-inspection report posted on its website, the FDA says it is reviewing serious deficiencies in McNeil's quality control unit, including allowing excipients with known bacterial contamination to be used in the manufacture of finished products.

At present it is not clear whether the contamination also affects the finished product themselves, but at the time of the inspection, those products were "within expiration date [and] on the market", notes the report.

It also indicates that the quality department did not have effective procedures for testing and approving drug products or indeed even the laboratory facilities able to test them effectively.  There were also cleanliness problems in the laboratory and general concerns about poorly-maintained equipment in production areas.

Moreover, McNeil failed to act on consumer complaints, including reports of products being contaminated with foreign materials, while training of staff in good manufacturing practices (GMP) was inadequate.

In a press briefing, FDA Commissioner Margaret Hamburg advised parents to make sure they do not use any of the affected brands. "There are many alternative versions of these medications available in generic form," she said.

Deb Autor, director of the Office of Compliance at the FDA's Centre for Drug Evaluation and Research (CDER), told reporters that the inspectors are currently preparing a 'narrative report' to run alongside the observations noted in the inspection document, which will be evaluated before additional action is considered.

McNeil has been trying to correct the deficiencies at the plant since meeting with the FDA in February, but at present "does not yet know whether those actions were sufficient," continued Autor.

Additional regulatory actions could include official warning letters, seizure of products and potentially criminal penalties, including fines. Last month, the FDA fined Genzyme $175 million for failing to correct deficiencies at one of its manufacturing facilities which led to medicine shortages.

Autor also noted that McNeil also makes solid dosage forms at the plant which will also be affected by the shutdown, but at present it is not considered necessary to ask for a recall.

In a statement, McNeil said it would "provide a detailed response to the FDA on their observations, and work diligently to ensure that they are addressed".

"We will not restart operations until we have taken the necessary corrective actions and can assure the quality of products made there," said the company.

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