FDA Flexes Muscles Against Shelhigh

We’ve heard of the FDA revoking approval, or issuing recalls. But we didn’t know they could seize products and block shipments — perhaps because it’s rare that a company lets things get that far.
Shelhigh is one such company. Makers of a heart valve fixative process for cardiothoracic surgery, they’ve been manufacturing with substandard practices for years, causing accelerated aging in their contaminated surgical implants, FDA alleges. After countless warnings, the FDA got tough:

A seizure is an enforcement action taken as a last resort to remove a dangerous product from commerce. The FDA initiates the action by filing a complaint with the District Court where the product is located, and a US marshal is then directed by the court to take possession of the goods until the matter is resolved. The complaint against Shelhigh was filed on April 16, 2007.
The US Marshal did not physically remove the devices from the plant but rather “seized them in place,” meaning Shelhigh cannot remove, attempt to remove or in any way interfere with the products without the prior written permission from the US Marshal. The firm’s products have also been embargoed by the state of New Jersey.
In fact, the story here is not that the FDA can recruit US Marshals and can function like the DEA when it needs to — the real story is that they waited five years between their first warning and their second, and sent a half-dozen increasingly shrill warnings over 18 months before finally acting in May:
It’s difficult to understand how Shelhigh believes it has a legal leg to stand on in light of the FDA’s last 7 years of warnings, threats and promises. Investigators documented deficiencies in the firm’s Union City facility in 2000 and 2005, and those inspections resulted in warning letters to Shelhigh in April 2000 and December 2005.
A December 14, 2005 warning letter spelled out what Shelhigh was facing. “Your failure to comply with any post-approval-requirement, the FDA explained, constitutes a ground for withdrawal of the Human Device Exemption and commercial distribution of a device that is not in compliance with these conditions is a violation of the Federal Food, Drug, and Cosmetic Act.”
…As for its part, according to Mr Gaudio, the FDA would not comment on why it waited 5 years between warning letters and then nearly a year-and-a-half between the December 2005 letter and the seizure, or why it then waited 2 more weeks after the seizure to send Shelhigh a formal request for a product recall.

More from the FDA…
Shelhigh’s perspective…