Yet another facility run by an Indian drugmaker has been tagged by the FDA. The latest belongs to Cadila Healthcare, which was cited by the FDA for failing to follow good manufacturing practices at a new facility designed to make injectable meds for sale in the US. More specifically, a June 21 warning letter cited problems with microbiologists failing to follow basic procedures.
For instance, microbiologists reported that were no problems with microbiological plates when, in fact, a colony-forming unit - which is a measure of viable bacterial or fungal numbers - was found. And a microbiological growth was incorrectly identified and reported as a typical microorganism when compared with an in-house library of typical environmental flora.
This may seem like so much inside baseball, but as the FDA notes in its letter, "accurate and reliable microbiological data is essential to support the aseptic processing operations used during the manufacturing of sterile finished drug products intended for distribution in the US." In other words, this is serious business and may prompt the agency to prevent Cadila meds from entering the US (read the letter).
Cadila isn't the only Indian drugmaker to face FDA scrutiny over manufacturing practices as the agency struggles to assert its authority over foreign drugmakers and ingredient suppliers in the wake of ongoing controversy and concerns about the pharmaceutical supply chain (read here). A notable instance was the contaminated Heparin scandal that was blamed for dozens of deaths (look here).
In recent months, the agency has taken action against Dr. Reddy's Laboratories for failing to properly validate methods for testing active pharmaceutical ingredients at a plant in Mexico (see this) and restricted imports from a plant run by Aurobindo Pharma, which supplies some meds to Pfizer (read here). Meanwhile, Ranbaxy Laboratories continues to chafe under an import ban on 30 meds issued three years ago for allegedly falsifying records resulting in the production and sale of meds failing to meet FDA standards. A resolution, however, is reportedly close at hand (see this).
5 Comments
The security codes are here to stay, aren't they?
Ho hum.
Your timing is impeccable on this one Ed. I guarantee that some of these microbiologists were told to turn a cheek from "atypical" growth, and pressured to do so. This is common. This is dangerous. This is fraud. I've seen and experienced much worse. And in the end, who suffers? The "incompetent microbiologists" that was stuck between the science they knew was correct (India has a slew of excellent microbiologists because of their potable water problem) and not insubordinating against their managers. And at times, managers, to shake the warning letter will point the finger at the people instructed to falsify data and simply fire them while hiring new blood at a lower salary.
Two birds with one stone!
The only way this problem can be solved is by brave people from within, not putting up with this crap, and exposing it in any way, shape, or form.
MMQC
Yes! I as well am going blind with the security codes.
;-)
Comparing identified bacteria to in house environmental isolates is irrelevant if a common in house flora is Pasturella, or rat decomposers...
DM
Technically, it's not necessarily out of compliance to state there was no problem with a plate with one CFU, especially if it's a benign organism (such as staph epidermidis, which is almost always contributed to benign skin flakes from the operator that performed the test. Hot in the lab? Sweating? You're shedding a boatload of bugs, which is why most aseptic manipulations are performed inside a controlled hood.
Which is why not having more than three out of spec results in a decade or more when the dedicated operator performs her testing outside of a hood, with food in her drawer, wearing the same labcoat worn in the bathroom and breakroom, - is just a flat out statistical impossibility. Whether you "believe in investigations" or not.
By the way, these security codes are making me cross-eyed.
;-)
It looks like the FDA imposed a FDA Import Alert on Dr. Reddy's Mexican API and intermediate facility:
http://www.reuters.com/article/2011/07/07/drreddys-idUSL3E7I70AL20110707
Here is the link to the FDA's 6-28-11 66-40 Import Alert list. Scroll down to Mexico: http://www.accessdata.fda.gov/cms_ia/importalert_189.html
Also, it looks like a few things are exempt.
Sorry to be a pain, but wanted to know if there is any way to make the security code number colors different from the security code numbers?