FDA Cites Cardinal for Sharps Containers
Cardinal Health received a warning letter after an FDA inspection revealed several quality-system violations related to some of its needle-disposal containers.
The company, for example, did not evaluate or investigate four complaints about needle sticks to determine if its Secure Safety Insert Systems caused or contributed to the events, the letter said.
It added that Cardinal has not developed a complaint-handling procedure for the sharps containers for which it is the specification developer and distributor. The containers are used to dispose of needles that inject radiopharmaceuticals.
During an April inspection of Cardinal’s Dublin, Ohio, facility, the FDA observed several violations, stating in the letter that quality system procedures had not been established for the containers.
The firm also was cited for not establishing acceptance activities for the containers, which are made by a contract manufacturer. Cardinal does not perform any testing on these devices when they are received, the letter said. The firm did not have a written quality agreement or receive a certificate of conformance from the manufacturer.
A Cardinal spokesman said the citations did not raise any issues with the product. He said Cardinal has implemented corrective actions, which the FDA is reviewing. The warning letter is available at www.fda.gov/foi/warning_letters/s6788c.pdf.