The US Food & Drug Administration has issued a stern rebuke to Bristol-Myers Squibb about manufacturing violations at its plant in Puerto Rico which had not been corrected and warned that this could affect future approvals.
The agency has published a letter sent to chief executive Jim Cornelius following B-MS' response in April to criticisms made by the FDA after an inspection of the manufacturing facility in Manati, Puerto Rico. That response "lacks sufficient corrective actions", the regulator states, claiming that "your firm has not established or followed appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile".
The letter goes on to say that "the operators at your facility have repeatedly failed to comply with your procedures for aseptic operations" and not "thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed". The FDA also states that "your firm has not established scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity".
The agency adds that "you should take prompt action to correct the violations cited in this letter" as failure to do so "may result in legal action without further notice including, without limitation, seizure and injunction". The FDA goes on to say that it may "withhold approval of requests for export certificates, or approval of pending drug applications listing your facility" until the violations are corrected.
The letter concludes by stating that due to these "continuing current good manufacturing practice issues...we recommend you engage a third party consultant having appropriate CGMP expertise to assess your firm's facilities, procedures, processes and systems to ensure that your drug products have their appropriate identity, strength, quality and purity".
The FDA gave B-MS 15 working days to reply and given that the letter was dated August 30, time is of the essence. However it appears that the New Jersey-based major has the situation in hand.
Sonia Choi, director of business communications at B-MS, told PharmaTimes World News that the company had met with the FDA to discuss the problem in August before the letter was sent. Since that meeting, it has initiated corrective measures and has already engaged the services of a third-party consultant, as suggested by the agency, she added.
Ms Choi concluded by saying that B-MS takes the FDA's concerns very seriously and will complete its response within the timeline set by the agency.