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.