The US Food and Drug Administration (FDA) has warned medical device maker Becton Dickinson (BD) for good manufacturing practice (GMP) violations at the company’s Franklin, Wisconsin facility.
The warning letter comes after two-and-a-half-month inspection this summer during which FDA found the company’s pre-filled heparin lock flush syringe and pre-filled 0.9% sodium chloride lock flush syringe products to be adulterated.
The warning is BD’s second in 2018 after FDA cited the company in January
over changes made to its Vacutainer blood collection tubes without notifying the agency of those changes.
In the warning letter, FDA cites the company for five GMP violations related to control of environmental conditions, bacterial contamination and failing to adequately monitor production processes.
According to FDA, the company used municipal tap water in two cleaning and disinfecting solutions used on surfaces in Class 10,000 cleanrooms and Class 100 laminar flow hoods where the company’s syringe products are aseptically filled.
FDA says the tap water is a potential source of contamination and cites the company for not routinely monitoring the water for microbial load to ensure that dilutions are effective for cleaning and sanitation.
During the inspection, FDA identified bacteria on the surface of Class 100 laminar flow hoods in three different cleanrooms. In response to the Form 483 issued at the end of the inspection, BD committed to making corrections to address the contamination, including discontinuing the use of tap water in favor of a ready-to-use disinfectant or cleaning solutions diluted using sterile water instead.
FDA also says that BD failed to put in place procedures for “establishing, controlling and verifying the acceptability of process capability and product characteristics” as the number of syringe units the company pulled for sterility testing “may not represent the manufacturing capabilities for all hoods and operating conditions.
Additionally, FDA says the company failed to adequately monitor processes to ensure that its devices conform to specifications.
Specifically, FDA says the company’s environmental monitoring program “does not require monitoring of the Class 10,000 janitor room and pre-gowning room located in the Class 10,000 clean area” used to produce sterile saline- and heparin-filled syringes.
FDA also says the environmental monitoring program did not require monitoring cleanroom employees’ gloved fingerprints contrary to ISO 13408 specifications.