FDA opts for 'effective remedy' with Triad

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.

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.

- here's the FDA statement

Free Webinar

What could you do with real-time supply chain information at your fingertips?

Interested in complete supply chain real-time data visibility? Unlock productivity with digital workflows, manage plants inventory with real-time supply chain information and enable faster decision-making with data visualization with pci | bridge. Register today!

Suggested Articles

With a slate of vaccine authorizations on the horizon, vaccine execs from a trio of leading shot makers are looking at distribution hurdles ahead.

News of an FDA plant inspection for a Macrogenics drug boosted investor confidence in BMS' ability to meet its year-end deadline for liso-cel.

Pfizer is pushing back on a Thursday report claiming it suddenly revised its COVID-19 vaccine targets for 2020, saying it announced that last month.