In a warning letter to Becton Dickinson Medical System, the FDA said the devicemaker must further document its corrections to problems with environmental conditions and safeguards against contamination.
The FDA inspected the facility earlier this year and found it had used municipal tap water, which has been found to be a potential source of microbial contamination, in cleaning and disinfecting solutions. In response, the company promised to discontinue its use, temporarily shut down manufacturing operations and permanently remove faucets and sinks from the janitor’s closet. The facility also pledged to validate and establish a revised, risk-based cleaning program based on a broader assessment of potential microbiological contaminants.
The inspection also found failure to establish procedures for cleaning or controlling operator practice in the facility’s cleanrooms where aseptic filling of saline/heparin syringes took place. Operators in the cleanrooms were observed touching gowns without sanitizing the entire surface of gloved hands and making rapid movements in the cleanrooms despite procedures requiring slow, deliberate movement. In response, the facility committed to only using sterile spray bottles to hold cleaning and disinfecting solutions, as well as to retraining employees on cleaning behavior and practices.
The FDA further faulted the company on its sterility testing for syringes. In response, the company pledged to revise its sampling SOPs, increase the minimum number of syringes required for lot sampling, and add a statistical method for establishing viable alert and action limits.
The company also did not validate either the unidirectional airflow of the laminar flow hoods used for aseptic filling of syringes or the removal of residue of disinfecting and cleaning solutions in the flow hoods, according to the FDA. The facility promised to perform unidirectional smoke studies for the flow hoods.
Lastly, the company did not integrate alarm systems into the laminar flow hoods/cleanrooms to alert employees of a loss in HEPA filtered air, and its environmental monitoring program did not require daily monitoring of the gloved fingers of all cleanroom operators engaged in aseptic syringe filling. The company said it would install and validate continuous monitoring equipment on all flow hoods and cleanrooms.
While all of the firm’s responses appear to be satisfactory, the FDA noted that several are ongoing and the agency would conduct a follow-up inspection to verify compliance.
Read the full warning letter here: www.fdanews.com/10-11-18-BDMedicalSystems.pdf. — Zack Budryk