The FDA last month sent a warning letter to Bristol Myers Squibb for repeated manufacturing at its facility in Manati, Puerto Rico, and threatened that future drug approvals could be at risk, according to the letter, which you can readhere.
Among the problems was a failure to prevent contamination, investigate subpar batches and supplying clean gowns for the clean room. The plant, by the way, makes several drugs, including the Abilify schizophrenia med and the Orencia rheumatoid arthritis treatment.
The FDA has warned the drugmaker about its plant. Last March, an inspection found workers did not comply with practices to keep areas sterile and there were similar problems noted there in past year, according to the agency letter.
2 Comments
It appears that just about all these articles are very negative to the drug companies. They look to be a bunch of thieves, which apparently they are. They need a dust cropping aka fumigation.
Also, not a good place to put your investment dollar. Who knows where it's going!
This could be like the sinking of the Titanic. They better deal with the situation and correct the PRACTICES that are putting the aseptic character of product in question. If they keep the same track they have followed in the past, they will sink. I hope they change course fast and have a positive resolution of the problems.