According to the Food and Drug Administration (FDA), USA, there is “growing concerns about the quality of the company’s manufacturing process.” The FDA informs that there have been some consumer recalls and unsatisfactory inspections, according to Deputy Commissioner Joshua Sharfstein, at a congressional hearing today.

McNeil Consumer Healthcare facilities have been inspected at an increasingly more frequent rate recently. In February this year the FDA met with the company’s management, Sharfstein added.

Sharfstein wrote:

Although the public risk from these quality problems is low, these problems should never have occurred, and the failures that caused them were unacceptable.

The hearing occurred amidst the largest recall of non-prescription (OTC) pediatric mediations. Over two-thirds of the pediatric retail medical market was taken off the shelves.

In April 2010, McNeil Consumer Healthcare Division recalled all unexpired lots of certain OTC (over-the-counter) Children’s and Infants’ liquid products, including Tylenol, Mocrin, Zyrtec and Benadryl, manufactured in the USA and sold in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.

In April FDA inspectors revealed a range of lapses which included filthy equipment, the potential of some medications being too strong, and bacterial contamination of ingredients. According to Sharfstein, similar lapses had been spotted before 2009, however the company generally sorted them out. In May and June 2009 inspectors detected a series of problems; they said the company was not meeting its own standard of quality in one ingredient for OTC liquid medications.

The aim of the House committee is to investigate the recall, learn more about the company’s lapses, as well as the FDA’s oversight.

During the House committee hearing, Rep. Darrel Issa (R-Calif) asked Deborah Autor, a director at the FDA’s compliance office whether “a potential criminal liability” exists as a result of the recalls.

Autor answered:

Well, it has been referred to the FDA’s crime division..

To which Rep. Issa responded:

I’m going to take that as a yes, that there are potential criminal charges and indict.

William Weldon, CEO, Johnson & Johnson had to decline an invitation to appear at Thursday’s hearing, due to health reasons.

According to Sharfstain, the FDA needs more authority, such as the power to order recalls when it finds quality problems. He said that companies have to voluntarily recall products.

Source: FDA, Reuters, CNN.

Written by Christian Nordqvist