E-mail updates
Follow on Twitter
Subscribe to RSSFrom a leaking ceiling in the so-called "clean room" and a bird flying through a room where sterile drugs are packed to basic problems with contamination and failures to investigate patient harm, the sister firm of the pharmacy at the heart of the deadly fungal meningitis outbreak had serious flaws in its drug-making process, federal officials said Monday.
Food and Drug Administration officials found conditions at Ameridose LLC of Westborough, Mass., so alarming during the month-long inspection between Oct. 10 and Nov. 9 that the agency urged the company to recall all of its products on Oct. 31 because there was no guarantee they were sterile.
Ameridose is co-owned by Barry Cadden, the owner of the New England Compounding Center, the pharmacy blamed for fungal meningitis infections that have sickened 438 people in 19 states and caused 32 deaths. Cadden and his brother-in-law, Gregory Conigliaro, started both firms.
The new inspection included complaints of pregnant patients hemorrhaging after being given the labor-inducing drug oxytocin made by Ameridose, and reports of patients being over-sedated on the painkiller fentanyl -- or having no effect despite being given the maximum dose of a common children’s anesthesia drug, midazolam.
“Your firm’s Quality unit failed to appropriately classify ‘patient response’ complaints as adverse events,” the FDA inspectors wrote.
The report on Ameridose described cracked and peeling walls; gaps under the clean room doors; insects and “at least one (1) bird” observed flying in the room where sterile drugs are packaged and stored. Similar inspections of NECC found filthy conditions in some rooms and both bacteria and fungus in packaged drug products made there.
No infections have been linked to Ameridose products, FDA officials said. But the possibility of serious harm is evident in the report that details 15 observations, including two that were first documented in 2008.
Those two were basic violations: failure to test finished drugs for sterility and for bacteria, as well as failure to confirm the potency of the final products.
Other problems included failure to investigate 53 instances of microbial contamination in sterile stock drugs used to make widely used injection drugs such as fentanyl and morphine, the new documents show.
In addition, firm officials also didn’t look into three instances this year when drugs failed sterility tests and they ignored 45 instances in which bacteria and mold were isolated from critical areas such as the fingers of workers preparing drugs inside sterile hoods.
Even when Ameridose officials did detect microbes, they failed to subculture them to find out precisely what they were, despite finding multiple contaminated units. Nor did they identify microbes found in the environment.
“Without knowledge of identity of microbes found during environmental monitoring, your firm lacked critical information to investigate possible root causes of sterility problems,” FDA inspectors wrote.
Ameridose officials defended the company's practices in a statement:
"While Ameridose’s history shows clearly that we have not had any instance of contaminated products over the course of the past six years, which covers the manufacture and shipment of 70 million units of product, and have always been guided by Good Manufacturing Practices (GMP) referenced in federal regulations, Ameridose is committed to addressing all observations in order to enhance our existing systems. We are in the process of preparing a full response for presentation to the FDA.”
Related stories:
- More die in fungal meningitis outbreak; pharmacy chief fired
- Some infections thwart treatment in fungal meningitis outbreak
Leave a Comment:
STexan and others who might want to bash governmental control and authority, it is important to realize that compounding pharmacies are a concern due to falling between the gap between federal and state control. Big drug companies, and I can personally attest to this, have stopped making cheaper medications altogether. The responsibility had fallen to state centered compounding centers and this situation will repeat itself unless it is addressed nationally. Two things I find interesting. One, the whole problem could have be avoided years ago if they gave Big Drug companies a tax incentive to keep the cheap drugs they make into play. Two, the people who are the first to complain about big government fail to realize that , as much as they also support state rights, it can be in conflict with overriding national interests, like health. Those areas require strict central control , for at least the possibility of our well being,though not a given.
Wasn't Johnson and Johnson cited for this as well? Seems quality control is taking a back seat to consumer safety.
lmao...too little too late
wtf are we waste tax $ on this bs? and whose job was it to check this company out?
someone should be charged with manslaughter...maybe the whole FDA?
Way to deflect responsibility from the person who did it to the person who caught them doing it.
You're one of the person who make sarcasm hard to detect, I refer to you in a previous comment.
Cincy - FDA does not have authority over compounding phrmacy - thank Dubya for that.
FDA approves the sale of cigarettes to white trash - smoking must be healthy!
Follow the money and see who is connected to this company.
I ve been reading about this/these Nasty Filthy so called labs for some time now and I haven't seen too much of anything about the owners being brought up on any criminal charges like murder assult etc...It is about time they should be charged with something other that operating a filthy lab
No one will have criminal charges brought. Remember, companies have taken over the legal system in this country. They are individuals with free speech rights but yet somehow when millions and millions of people the world over are ruined financially or out-and-out killed by their ineptitude, no one goes to jail. Weird about the press reports that if YOU don't pay your bills, they now have debtors prisons just waiting for you.
This is already an oligarchy and the plutocrats have taken over. It is just that no one bothered to inform the public. Gee, could it be because the press is now part of the oligarchy?
We are totally screwed.
I never understand how these types of situations are possible. I work in and have worked in the health care/heath science field for 30 years. Everywhere I have ever worked has regulatory agencies or accrediting agenciess inspecting the facilities and or its workers, the equipment, air quality... multiple times throughout the year
Frostbit - I suspect you work in a clinical enviornment, unfortunately manufacturing is a bit different. Pharmaceutical companies (MERCK, Lilly etc) are under FDA regulation and are supposed to be audited for sanitation, in addition to having to submit new drugs for testing and efficacy, they are required to track issues, meet strict labeling requirments all sorts of neat regulatory stuff. These companies usually have quality and regulatory compliance staffs to help make sure they comply, and on the whole their managment acts responsibly. Than there are the neutracutical companies (al those GNC type vitamins etc) they are specifically not regulated by the FDA by an act of congress - they did not want to have to provide efficacy type data, but again I would bet they are fairly clean. Compounding Phramacies like the outfits that are involved in the current mess are regulated by STate Boards of Pharmacy - when proposed to put them under FDA congress and Bush weren't keen on regulation - State boards of pharmacy probably aren't equipped or trained to inspect some of these places, and it is my inderstnading that they really are not supposed to be doing large batch proccesses they are to be a specialty shop.
This incident, the problems with Peanut COrporation of America last year (bunch of folks got sick on E.coli infected peanut products) and other food and drug incidents over recent time, makes it real obvious that the FDA is way underfunded and unfortunately many of my collegues (in Food or Drug Quality and Product Safety) are not doing their jobs.
Congress: give the FDA the strength to close dangerous drug manufacturing plants. We have regulations and laws, but, they are toothless without the strength for those responsible for our health and safety to shut down non-compliers.
"Laissez-faire" was what a bunch of crooked French businessmen told Napoleon's Minister of Commerce he should do after the revolution, it basically meant "let us do whatever the f*** we want to."
"Caveat emptor" means "Buyer beware," or in Modern English, "A sucker's born every minute."
As far as I'm concerned, the Ayn Rand libertarian gypsy crooks who want the right to bait-and-switch us on everything from medicine to municipal funds can shove their "caveat emptors" up their "laissez faires" 'till the hilt disappears from sight.