A former Ameridose employee is blowing the whistle on what she calls potentially deadly safety hazards at the now-shuttered drug manufacturer and supplier, hazards she says management tried to cover up when investigators came knocking.
The former employee worked at Westborough-based Ameridose until the company laid off all its employees in the wake of the tainted drug scandal that engulfed its sister company, New England Compounding Center. Injected steroids distributed by NECC have been linked to more than 30 deaths nationwide.
"We were devastated. Not just me, but a lot of employees," the former employee told FOX Undercover reporter Mike Beaudet. "Because we had no idea that they were sending things that weren't sterile to different companies."
Ameridose was started by the same men who founded NECC: Barry Cadden and Gregory Conigliaro. State and federal investigators found a slew of problems at NECC after the meningitis outbreak, including failures to sterilize products.
Investigators also found problems at Ameridose, prompting the company to voluntarily recall all of its unexpired products and lay off more than 600 people, including the whistleblower.
In a US Food and Drug Administration report released last month, investigators found 15 issues at Ameridose, raising more questions about the sterility and safety of its products.
Among the findings were that "equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination" and that "each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements."
"I think it's horrible," the former employee said. "Just finding out about Ameridose not testing their medicine when they're sending it causes a hazard. And it could cause deaths just like it did for NECC because obviously they weren't testing anything."
She says another of the FDA's finding, that buildings "are not free of infestation by rodents, birds, insects, and other vermin", was not surprising.
"Well the insects, we did know about. I mean that was a problem probably since 2010.
People were like, ‘There's stinkbugs everywhere. There are birds flying.' There were other flying insects. People would talk about it," she said.
"We did see other flying insects come into the clean room from time to time but we were just told to spray the orders down, it's okay after they were killed," she added.
The former employee says managers at Ameridose became nervous after the deaths linked to NECC surfaced and they knew inspectors would be visiting Ameridose.
She says managers started ordering employees to do things they usually didn't do such as going back and adding product testing sheets in the orders for drugs to make it appear that certain testing had been done.
"No one had ever done this before?" Beaudet asked her.
"No," she replied.
"Why do you think the company was doing it now?" Beaudet asked.
"Well, we think now so it would look like they actually had a sterilization process," she replied.
"Did it seem like they were trying to cover something up?" Beaudet asked.
"Yes. Obviously their uncleanliness," she replied.
The former employee believes money motivated management to cut corners.
"They had a same day turnaround slogan at Ameridose. So it meant basically that every order that was placed that day, would ship that day. Except for narcotics, we were told," she said.
She says she's relieved carelessness at Ameridose didn't lead to any victims but can't stop thinking about the people who died because of what happened at NECC.
"Do you think this could have been prevented?" Beaudet asked.
"Definitely, if they were doing the right things," she replied.
Ameridose issued a lengthy statement in response to the whistleblower's allegations.
"Ameridose has always placed the highest priority on the sterility and safety of our products. This is demonstrated by the excess of 70 million units of product that have been shipped by Ameridose since it was established as an FDA-registered manufacturer in 2006. No issues of contamination have ever been linked to any Ameridose product.
Ameridose routinely tests its products for sterility and potency under our standard operating procedures. We follow rigorous procedures that require both the performance and documentation of cleaning and disinfection on a daily, weekly and monthly basis. Sanitation of materials going into the clean room, which may include spraying materials with alcohol, is a normal and routine process.
Ameridose has robust standard operating procedures in place to perform and document all activities, including all production processes to ensure the quality of Ameridose products. We are confident that these procedures are well designed to ensure the safety of our products. All staff are trained in these procedures during the course of their employment, and employees are required to follow all procedures at all times as defined in Ameridose standard operating procedures and training documents.
We have reviewed the comments that the FDA made on our processes after its inspection, and have undertaken a comprehensive review of all of our systems. Ameridose has informed our industry regulators of additional steps we will undertake to make our processes even more robust. We believe the net result of these efforts will be that Ameridose will be a model for its industry."
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