FDA Embarks on Warning Letter “Rampage”

August 24, 2016

Last week the FDA released an astonishing 23 warning letters along with an import alert to a number of companies located across the globe.  According to a recent article from Law360, the letters were sent to companies located in the US, Argentina, China, Europe, India, and the Philippines and included manufacturers of drugs, medical devices, and cosmetics.

More than half of the warning letters were sent to manufacturers of medical devices, “which were repeatedly accused of not processing complaints properly.”  In addition to medical device companies, FDA’s warning letters cited various companies for a number of different violations, including, but not limited to, the following:

  • FDA issued an import ban and safety alert on Laxachem Organics Pvt. Ltd.’s products, an Indian-based API manufacturer, accusing the company of “refusing to allow FDA investigators to inspect its facility.” FDA stated that “the ban will block US imports of all Laxachem products until the company agrees to a full inspection and is found in compliance.”
  • China-based Zhejiang Medicine Co. Ltd. received a warning letter containing allegations of various data integrity violations.
    • According to Law360, “the FDA warning letter said that employees repeatedly performed ‘unofficial analyses’ of drug products and then stored the results separately.” Subsequently, the separate results turned up major discrepancies that FDA feels could indicate the presence of unknown and uncharacterized impurities in Zhejiang’s drugs.
    • Furthermore, the company was also cited for “using common usernames and passwords on its computer systems,” which can lead to manipulation, data deletion, and unauthorized access.
    • Finally, FDA also stated that it witnessed Zhejiang’s analysts predating or backdating results.
  • FDA also sent a warning letter to Michael Todd True Organics LLC, a company that sells skincare products through retailers such as Amazon and Ulta, regarding “promotional statements that allegedly crossed the line separating cosmetics and drugs.”

Quality and compliance violations are among the most serious issues faced by drug makers.  As such, FDA does not take them lightly.  It is important to approach each project with consistency and accuracy in order to avoid issues involving the quality of your products.  Sometimes, despite your best efforts, you may still run into these or similar violations.  In these circumstances, you need to respond quickly and appropriately to avoid further regulatory action.

ProPharma Group can help ensure that your products are of the highest quality standards, and if they aren’t, we can help you get there.  We have significant experience in this area and we are uniquely qualified to help you with all of your quality and compliance needs.  To learn more about our services and how we can help you, contact us today.



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