FDA warns BMS over manufacturing plant in Puerto Rico
pharmafile | September 15, 2010 | News story | Manufacturing and Production |Â Â BMS, FDA, GMP, Puerto RicoÂ
A plant operated by Bristol-Myers Squibb in Puerto Rico has been cited by the US Food and Drug Administration for manufacturing violations.
A March inspection of the facility in Manati uncovered significant violations of GMP including a failure by staff to maintain sterile conditions in areas such as lyophilisation suites, which could lead to microbial contamination of drug products.
The FDA’s warning letter dated 30 August and addressed to BMS’ chief executive Jim Cornelius – suggests that BMS could benefit from hiring an outside agency to help it tackle the problems and implement a remedial plan.
Manati is used for filling-and-finishing of a number of biologic drugs in BMS’ portfolio, including Orencia (abatacept) for moderate to severe rheumatoid arthritis, and is the company’s only bioproduction facility in Puerto Rico.
Other products made at the facility include the cardiovascular drug Coumadin (warfarin sodium) and intramuscular formulation of Abilify (aripiprazole) for schizophrenia. The specific products affected by the violations have not been identified.
It is also responsible for making a number of investigational compounds. In its letter, the FDA noted that the violations could place any pending new drug approvals on hold until the problems are corrected.
Some of the observations in the letter were also encountered during prior inspections in 2005 and 2009, which suggests they could point to an overall weakness in the plant’s quality control.
A response filed by BMS to answer the FDA’s concerns was inadequate, according to the agency, which gave the company the statutory 15 days to give notification of its corrective steps.
Manati recently underwent a major investment programme to expand and refit the facility at an estimated cost of $220 million. It is one of two facilities – the other at Humacao – which survived a restructuring of BMS’ Puerto Rican manufacturing operations in 2007 and 2008.
Phil Taylor
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