In a rebuke to Mylan (MYL), the Food and Drug Administration warned the big generic drug maker about a host of manufacturing gaffes at a key plant in the U.S. that has been the focus of large job cuts this year.
Following an inspection last March and April of the Morgantown, W.Va., facility, the FDA noted that Mylan failed to clean equipment, investigate unexplained discrepancies in batches of drugs, and follow proper procedures to assure medicines have the intended quality and purity.
Moreover, the agency reminded the company of repeated violations at multiple sites that were found over the past three years. In 2015, three facilities in India were issued a combined warning letter for inadequate controls for making sterile drugs and failing to establish scientifically sound lab controls, among other things. Last year, a plant in India was given a warning letter for invalidating test results.
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STATPlus has been a great resource for us to determine whether or not we would be best to have some treatment protocols, from one source or another. I have actually been using this resource as a best way to choose the most efficacious treatment from another, and this is why a family member of mine is still alive. For this I am grateful for this source for our healthcare experiences.
For the past two months, I have been trying to obtain the Mylan Brand of an antiemetic medication I have always purchased from Mylan. I have been given the medication from the Airubindo Manufacturing plant located in India. I have tried to obtain the Mylan medication from a different manufacturing source that is not in the Pharmaceutical plant known as Aurobindo, thanks to the STAT column of a brief while ago; the plant is located in a large waterway that is filled with deadly toxins. Neither humans, nor animals are safe, if they ingest any of the pharmaceuticals manufactured in that place.
I have tried to find the Mylan brand that is also manufactured in this country ( which is now shut down because of the unbelievable manner of the safety regulations that demand the pharmaceutical companies to be pristine.
I just wrote to Mylan yesterday afternoon, because I finally found a pharmacy within a forty-five minute drive from my home to the pharmacy that I found; I explained the reason why I did not want the Auribindo Pharmaceutical medication from there. The pharmacist said that they have one bottle left, and I agreed to purchase the prescription for cash, as I had just had my refill of this medication from a different pharmacy, which did not fill the prescription as I indicated I wanted. So I ended up using my remaining refills for the Mylan from the extremely toxic and possible life threatening plant from India.
When my husband drove to the pharmacy where I explained all of this and why I don’t want anything from the plant in India, he came back with the Mylan blue bottle of my last refill for which I had to purchase with my own money ( my insurance company would not reimburse me even after I explained why I refused the medication free the plant in India ). I have been very ill for the past two months; I looked at the manufacturing label on the old bottles from Mylan ( I always keep the one prescription with refill bottles of all my medications, for any possible problem like the one I am writing now ), and I was furious to read the origin is from Aurobindo!
If I had not my subscription to STATPlus, I would have continued taking toxic medications from obviously everywhere Mylan is being manufactured. The pharmacist at the fairly new pharmacy ( I decided to change my life long pharmacy company for many reasons that finally were beyond my willingness to be treated so poorly by the head pharmacist, that is a very strong transference of her own psychological issues that I am the one that she uses ( or abuses ) myself and probably others too! I have never had any issues with anyone in the company that I was a lifetime patient; we have actually become friends with two local pharmacists, because we always treat everyone with the respect that we do for all other individuals.
The final point here is this: we are offered a life saving venue with our STATPlus subscription; it is imperative for us to read the valuable information that the countless individuals who have dedicated their journalism to keep us informed of everything that we would need to know. We have to do our part, and read the plethora of columns that have significance for ourselves and others too.
Thank you STAT; you have saved the life of a loved one; and you have helped to stop me from continuing to injest extremely toxic by products from unsafe pharmaceutical companies from around the world; and in our own country as well!