This blog is straight talk about quality assurance in the pharmaceutical industry. Not the technical aspects as much as the challenges faced by company management and their internal quality assurance professionals—sometimes side-by-side and often toe-to-toe.
Saturday, February 19, 2011
“Out of Abundance of Caution”—and Triad Group’s “One Concerned Customer”
“Out of abundance of caution” the Triad Group initiated a recall of all lots of Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks on January 3, 2011, due to “concerns from a customer about potential contamination of products with an objectionable organism, namely Bacillus cereus.”
Triad’s Press Release on January 5, 2011, continued to state that it had received “one report of a non-life-threatening skin infection.” The date of this one report was not given. (I suspect we won’t know that date until a Warning Letter comes out.)
Triad published a fact sheet about the recall on its website. They stated, “There has been ONE report of a potential contaminant out of hundreds of millions of products sold.” (Their emphasis, not mine.)
The contaminated product was recalled, but tragically, not before the product was used with the surgery of a 2-year-old Houston boy who allegedly died from acute meningitis due to Bacillus cereus on December 1, 2010. Use of the product has been confirmed. The parents have filed a wrongful death suit. “We’ve been devastated. We’ve been absolutely crushed.”a
Without going into a bacteriology lecture, suffice it to say, all the experts have weighed in on what every rank-in-file microbiologist in the medical products laboratory should know: Bacillus cereus is a very bad bug. This spore former is resistant to heat and tough to kill. That’s why it’s called an “objectionable organism”—it doesn’t belong in the product at any level.
“Concerns from a customer.”—one, just one customer—out of hundred of millions sold—one, just one customer. In the case of Bacillus cereus, it shouldn’t have to take more than one to crawl all over the problem.
My message to the Quality Department and those responsible for responsible for designing or operating the Complaint Handling System required by 21CFR211.198 and 21CRF820.198—sometimes it only takes one. Some complaints are so serious and potentially life threatening, that it just takes one. Don’t look for a trend.
With Triad’s one concerned customer, it’s not whether it was non-life-threatening to that one customer. Rather, it is all about Bacillus cereus.
I would have expected the “abundance of caution” at the Triad Group to be: (1) stop production, (2) recall all product, and (3) initiate a revalidation of all production lines—upon the first report of Bacillus cereus.
We don’t know yet the date of when Triad became aware of the first report. But I don’t get the feeling that the “abundance of caution” was very abundant.
UPDATED, February 25, 2011
On February 22, 2011, the FDA posted the FD483 related to this blog for the Triad Group’s parent organization, H&P Industries. Please go to this link:
It describes a fatal combination of inadequately developed processes; unvalidated sterilization processes; uncontrolled manufacturing environments; unqualified employees; failing sterility tests; and an irresponsible Quality Unit knowing releasing contaminated product into the market.
The 46 observations covering 30-page tell a story of nothing less than a foreseeable disaster. A ticking time bomb that is claimed to have caused the death of a two-year old Harrison Kothari of Houston and potential infections of more than 100 others according to the lawyers representing the Kotharis. 2
This surely will be a test case to see just how bad it has to be before the FDA takes action against individuals. (See The QA Pharm 9/11/10.)
UPDATED April 7, 2011
FDA Seizes $6 million in Products from Triad http://www.jsonline.com/business/119352799.html
The QA Pharm
1 Aleccia, JoNel, Parents blame toddler’s death on tainted alcohol wipes, msnbc.com, 2/15/11.
2Aleccia, JoNel, FDA defends actions at plant that made tainted wipes, msnbc.com, 2/25/11.