A company that was awarded a federal contract to produce Wuhan coronavirus (COVID-19) test kits has closed amid a flurry of complaints about contamination in those kits.
Founded in Florida on May 1 of this year, Fillakit was awarded a contract to produce liquid-filled plastic vials for COVID-19 test kits by the Federal Emergency Management Agency (FEMA) a week later on May 7. On June 26, less than two months after receiving that contract, the company notified the Florida Secretary of State that it had dissolved.
Fillakit under scrutiny for contaminated test kits
Prior to its closure, Fillakit was under scrutiny for issues with the conditions in the facilities where its test kits were produced. Several former Fillakit employees had come forth complaining about the unsanitary conditions in the companies production facility.
According to former employees, workers at Fillakit’s facility sat side-by-side, filling the vials by hand while cooling fans flew dust around. The dust would often get inside the test tubes, contaminating them.
“The environment is not clean at all and certainly not sterile,” stated Teresa Bosworth-Green. A retired science educator who worked at the company for about two weeks, Bosworth-Green said that she saw vials containing dust and even insects being packaged for shipment.
Meanwhile, an aide to California Rep. Jackie Speier confirmed that they had received an anonymous complaint from another Fillakit worker las June that said that the company was “delivering inferior and unusable product to the government without oversight or accountability to the taxpayer.”
Guidelines from the Food and Drug Administration (FDA) require the liquid-filled tubes to be sterile so that test results aren’t contaminated. These vials are where nasal swabs from patients tested for possible coronavirus infections are put into for transport to labs.
According to Catherine Klapperich, head of Boston University’s new COVID-19 research lab, dust, bugs and even exhalations from unmasked workers can contaminate the vials and produce false results. As such, these should be prepared and packaged in a completely sterile environment.
In response to the allegations, Fillakit manager Paul A Wexler told the Wall Street Journal that the accusations against the company were baseless. He stated that they had come from a former employee who was fired for making racial slurs, who he declined to name.
Since the company’s closure, however, Wexler has remained silent and not responded to various publications attempts to contact him.
Fillakit under government scrutiny even as it closes
As a result of the complaints, FEMA and the Department of Health and Human Services issued warnings for states not to use the testing supplies it purchased from Fillakit. State authorities, such as those in Missouri, have also ordered testing facilities not to use the kits.
At the same time, the Department of Homeland Security (DHS) also began looking into the matter. Talking to ProPublica, Bosworth-Green confirmed that she had already been interviewed by DHS agents about the company’s operations.
While defective coronavirus test kits have been reported before, most were kits that that were hurriedly sourced from China. In addition, most of the previous cases were with smaller orders, either by universities or state health departments. (Related: China made defective coronavirus test kits for Tanzania, reveals Africa CDC.)
It’s the size of the Fillakit order that raises eyebrows. Valued at around $10.2 million, the contract saw FEMA buy 4 million kits from Fillakit, 3 million of which had already made it to every state and U.S. territory before the reports of their contamination surfaced.
On Capitol Hill, the scale of the contract has caused Michigan Senators Debbie Stabenow and Gary Peters to ask FEMA to explain how Fillakit got the contract. Both senators wrote to FEMA, saying that the loss of the test kits now jeopardizes Michigan’s ability to life quarantine restrictions safely.
“The sudden and unexpected shortfall of hundreds of thousands of vials of transport media runs the risk of compromising [Michigan’s] ability to effectively detect and prevent the further spread of COVID-19.”
Suffice to say, this applies to all states that were hoping to rely on these kits, and not just Michigan.
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