The FDA this week released a warning letter it sent to Becton Dickinson (NYSE: BDX) last month over issues it found at the company’s Franklin, Wisc.-based facilities, which produces pre-filled Heparin and 0.9% sodium chloride lock flush syringes.
The warning letter came from an inspection of the facilities which took place between May 16, 2018 and August 1, 2018, and includes a response from BD that the federal watchdog received on August 21 this year.
In its letter, the agency outlined five issues it identified during the inspection, including environmental control and contamination issues, product conformity and product validation issues.
In its first point, the FDA said that BD failed to adequately establish procedures to control environmental conditions, specifically municipal tap water which was being used in the production process.
“The municipal tap water has been found to be a potential source of microbial contamination through FDA sampling. Your firm does not routinely monitor the municipal tap water for microbial load to ensure dilutions are effective for cleaning and sanitation,” the federal watchdog wrote in its warning letter.
The agency said that it already received a response which stated that the company has discontinued use of tap water and switched to ‘ready to use’ sterile disinfectant, among a number of other steps. The FDA said that the “response appears to be adequate,” but that since some of the actions were still in progress, a follow-up inspection will be required to verify compliance.
In its second noted infraction, the agency said that BD failed to establish procedures to prevent contamination of equipment or products.
The FDA said that it noted a number of issues related to contamination, including the use of disinfecting solutions which used non-sterile tap water, clean room operators not following appropriate sanitary instructions and the identification of a number of different bacteria found within Class 100 laminar flow hoods.
The agency again noted that the company had responded to the contamination issue and that the response “appears to be adequate,” but that it would need a follow-up inspection to verify compliance.
In its last three noted infractions, the FDA knocked the company on failing to monitor its production and validation processes, and said again that it has received a response from the company that would require a follow-up inspection.
In August, pharmaceutical manufacturer Julphar said that it inked a deal with BD to supply disposable insulin pens to the United Arab Emirates.
