German drugmaker Fresenius received a scathing warning letter in July for a drug plant in India. Now, a blood-products plant in Puerto Rico has been sent a warning for a labeling issue which the agency said should have been resolved months, even years ago.
The FDA Tuesday posted the letter that the drugmaker's Fenwal operation received for an inspection in April, a follow-up to a 2012 visit. Primarily, the agency was concerned about the company's failure to document and investigate customer complaints about mislabeled bags even although the products had already been shipped. "Our inspection in 2012, and the current inspection, found that you have received multiple consumer complaints related to mislabeled bags, inadequate bag size, defective product components, and product mix-ups" that were left unresolved.
Further, in a repeat violation, the plant was criticized for not writing a procedure to make sure that products get the right labels and procedures to "prevent mix-ups and cross-contamination" by keeping different products separated from each other, even though the facility has been getting complaints since 2010 about the problem. The agency was also upset that the plant still wasn't submitting field alert reports, or FARs, even though it was told in 2012 that it needed to. As a result, the company now is having to recall its Adsol blood preservative as well as an anticoagulant solution, the FDA pointed out.
The agency focused in on the plant's quality control unit, saying it was relying on customers to identify problems that should have been corrected at the plant. The complaints show that the unit is not "fulfilling its responsibility to assure the identity, strength, quality, and purity of your licensed biological drug product(s)," the letter says.
In July, the company's oncolytic API plant in Kalyani, India, was savaged in a warning letter that said employees lied about having blended APIs that failed quality tests into batches that passed in an effort
As I just stated in another post, spending much time here is a waste of time. Everything but the last chapter of this story has been debated ad nauseum, the lies from the bash trash whack pack have pretty much been taken on and eliminated by anyone who can reason things out and don't get sucked in by their cherry picking contortions and distortions. So why bother...we just have to wait until this is settled and I believe that is not all that far away.
The agency focused in on the plant's quality control unit, saying it was relying on customers to identify proble in an effort to hit specifications. It documented employees confessing to manipulating data to hide problems from the agency. They told inspectors that when it was known there was going to be an inspection, high-pressure liquid chromatography equipment and personnel computers were removed from the plant to "conceal data manipulations."
And there were so many bash trash saying "COULDN'T POSSIBLY FRESENIUS' PROBLEM"...RIGHT!!!
Not bashing - seeking to understand, but didn't one part of the thesis say that if there were quality control problems, then the issues would have been more widespread? Possibly the more wide spread population (0.2) who had reactions is part of the quality control issue, not just the 3 patients who seem isolated to 2 centers and one company.
Sentiment: Strong Buy