The Warning Letter to Claris Lifesciences was one that went on and on, page after page citing violations of fundamental, block-and-tackling practices. This was surprising and a disappointment given that Claris is one of the largest sterile injectable pharmaceutical companies in India with a market presence in 76 countries worldwide.  From a patient’s perspective, their products are injected directly into the human body and are used in the treatment of critical illnesses.

So extensive is the Warning Letter that it is organized into sections that conveniently walk the reader through the logic of the inspection: CGMP Violations (that cover the gamut), Field Alert Reporting Violations, Unapproved New Drug Violations, Adverse Drug Experience Reports, and a Conclusion.

In layman’s language: you are not operating in a state of control, you are not reporting the product problems, and you are even introducing unapproved products into interstate commerce.

This Warning Letter, issued on November 1, 2010, might be viewed as another example of the FDA interest in contract manufacturing operations. (FDA considers Claris a CMO.) To me, however, it appears to be a combination of Rick Friedman’s interest in sponsor oversight of CMO’s as well as the general trend of the Agency toward accountability.

Why? Get this.

To my recollection, client/ distributor names associated with the problem products are usually not mentioned, or at the very least have been redacted before being posted. In this case Sagent Pharmaceuticals and Pfizer get honorable mention for the world to see as being distributors associated with Claris’ problems.

Another interesting feature of this Warning Letter that it is fairly direct in stating what the FDA expects to see in Claris’ response. For each observation, there was a paragraph that began with: “In your response to this letter, include…”

For example, FDA requested:

  • Explain your failure to initiate the complaint investigation promptly.
  • Explain the discrepancy between finding fungi in the IV bag as well as the overwrap and reporting that no leak or contamination was found.
  • Explain why defective parts were being used and how the supplier of these defective parts was qualified.
  • Explain how and when Claris identified and informed all customers affected by your IV bag manufacturing problems.
  • Explain why other products filled in the same packaging line, with the same bags and printing process, were not affected or contaminated.

“In conclusion,” wrote the FDA, “you are under FDA Import Alert so we will refuse admission of your products into the U.S…”

That’s a pretty big conclusion statement.

This is unfortunate indeed, given their medically necessary products including anesthesia, plasma volume expanders, nutrition and oncological infusion therapies.

I’d say that the FDA delivered not just a shot over the bow, but rather a direct hit—and Claris is taking on water. Unfortunately, the availability of medically necessary products to needy patients is going down with the ship.

Are there any remaining questions about CGMP compliance and its relationship to being able to compete in the marketplace, or patient impact?

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republished with permission from The QA Pharm