FDA opts for “effective remedy” with Triad

FDA opts for “effective remedy” with Triad

April 14th, 2011 // 9:21 am @

The FDA’s seizure of $6 million in products from Triad Group, “to stop Triad from continuing to distribute products which may pose a risk to public health” as the agency says in an announcement, marks the latest step in the entanglement of the two. And it’s not likely to be the last.

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U.S. Marshals took antiseptic products, cough and cold drugs, nasal sprays, suppositories and other products, in addition to in-process products and raw materials, from the Hartland, WI, facility. Last week’s action follows several microbial-contamination product recalls beginning with alcohol prep pads in early January.

An early March wipes recall generated news coverage by MSNBC that introduced a general audience to the FDA Form 483 inspection report. The news report described some of the 46 citations from a late 2010 inspection. Form 483 inspection reports and warning letters are common enough. Product seizures, however, are a different animal.

“Seizure of drug products is an effective remedy when there is evidence of continued poor compliance with cGMP requirements,” the FDA says in a statement. “Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.”

That’s appears to be the case with Caraco. Following the seizure of $33 million in products from its Detroit-area facilities in June 2009, the company came under consent decree with the FDA. As of January, it was still working on fixes.

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