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Friday, May 28, 2010

Dozens of Drug Factories Received FDA Warnings Since 2009

Since the start of 2009, at least 43 drug factories producing pharmaceutical products sold in the United States have received FDA warnings for failing to correct problems which may place consumers' health at risk.

Some of the violations resulting in warning letters from the Food and Drug Administration (FDA) include:

  • Using equipment and ingredients contaminated with bacteria or insects
  • Failing to do proper testing to ensure drug strength and purity
  • Ignoring consumer complaints that products made them ill

The warning letters issued by the FDA only dealt with the most egregious violations found at factory inspections. However, a substantial number of factories which did not receive warning letters were cited for lesser violations. According to the FDA, between 2002 and 2006, more than 50% of domestic plants and 62% of foreign plants supplying drugs to the U.S. received violations which required correction but were not egregious enough to warrant a warning letter.

The following plants received warning letters from the FDA for egregious violations:

  • Teva Pharmaceuticals received a warning letter for failing to properly test propofol, used by anesthesiologists during surgeries, after 41 patients developed post-operative fever. Teva recalled propofol due to the bacterial contamination.
  • Hospira, another company which manufactures propofol, recalled the drug due to steel particle contamination.
  • Balchem, an Illinois plant manufacturing calcium carbonate used in antacids and menopause drugs, received a warning after they released products to the public which were made with water contaminated with coliform bacteria. Balchem new the products contained contaminated water at the time of their release.
  • A Massachusetts plant run by Braintree Laboratories received a warning for failing to investigate 21 complaints of bug parts or spiders in several of their products.
  • A Puerto Rico plant manufacturing products for Procter & Gamble received a warning letter after FDA inspectors found bacteria on equipment at the plant. The company was also cited for failing to investigate 198 complaints regarding health issues linked to a Vicks Sinex product manufactured at the plant.

If you have suffered an injury after taking a contaminated or defective drug, the pharmaceutical injury attorneys at The Cochran Firm can help you receive compensation for your damages.

Please contact our experienced pharmaceutical injury attorneys today to schedule your free initial consultation. The Cochran Firm serves clients nationwide.


posted by Benjamin A. Irwin at 7:30 AM

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