It turns out that you can't trust what Shelhigh says at all—about the FDA's complaints or about an agreement reached with the FDA in court about a month ago.
Shelhigh is a manufacturer and distributor of tissue-based medical devices, implanted in patients during surgery, including during organ transplant operations. On April 17, the FDA had U.S. Marshals seize all devices at the company's plant in Union pursuant to a court order. That order was founded on facts set out in an 11-page written statement (the "Complaint") filed by the FDA.
Soon after the seizure, Shelhigh put out a press release saying the FDA allegations were unfounded, that they didn't know what the FDA was complaining about, and that the FDA was not communicating with them and was simply conducting a "baffling" campaign to financially ruin them.
In fact, the 11-page complaint would almost certainly have been delivered to Shelhigh at the same time the Marshals seized the inventory, and if for any reason was not so delivered, it is on the FDA website (where I found it). The FDA complaint includes almost seven full pages of detailed allegations as to what was really going on at the plant.
The allegations contained in those seven pages include the following, just as examples from the long list of complaints:
- Shelhigh proved the sterility of a product lot by taking samples from devices within the lot that failed the initial "leak" testing, mixing those together, testing them for sterility and then passing them off as samples taken from the finished lot which went on to be processed by human hands before completion.
- In the last two years, Shelhigh released for distribution four lots of devices that failed even their sterility testing, and two lots that failed endotoxin testing. (Endotoxins can cause fever, shock, coagulation of blood, and a rapid fall in blood pressure when introduced into blood or tissues of the body.)
- An independent lab test showed that 7.4% of samples tested in 2005 and 5.7% of samples tested in the first 10 months of 2006 failed sterility testing.
- The company's "clean room" was anything but: There was no separate gowning room for employees entering the clean room, they didn't put sterile covers over their shoes as required for full gowning, and they went in and out of the clean room (including to restroom visits) in the same gowns. Also a non-sterile steel cart was taken into the clean room during processing and the room was cleaned by sweeping with a broom (therefore dispersing dust, bacteria and mold spores throughout the room and onto other surfaces) during the routine disinfection of the room.
- The controlled manufacturing rooms adjacent to the clean room, where bovine and porcine tissue products are processed, had all sort of nooks and crannies where bacteria could lurk and grow: dirty surfaces on the ceiling, missing and broken ceiling tiles, and air diffusers with an accumulation of corrosion and dirt.
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Since then, Shelhigh and the FDA agreed to a settlement to provide for the release of the seized devices. See Part 2 of this article for Shelhigh's outrageous spin on the consent order made pursuant to the settlement.
Fasten your seatbelts.