FDA Warns Swedish IVD Manufacturer
The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 20 September to Malmo, Sweden-based Euro Diagnostica AB, which manufactures multiple class II in vitro diagnostic (IVD) devices.
The warning, following an inspection last January, features at least five violations, including one related to the company’s decision to not recall an assay used to detect anti-nuclear antibodies after receiving complaints of a higher incidence of false positives that the company investigated and confirmed.
FDA says the company received complaints in 2015 relating to this increased ratio of positive results, but after investigating, "made the decision to not conduct a recall despite your standard operating procedures (SOP) and the confirmation that the higher incidence of false positive results was confirmed."
The firm’s Quality Review Board (QRB) also decided to inform affected customers and offered to replace the kits.
"However, the QRB also determined that there is no patient risk involved for these batches and a recall of affected batches was not required. Your firm did not report these actions to FDA," the letter says.
The agency adds that it’s necessary to have evidence of procedures to address complaints in a timely manner to ensure concerns about product safety are quickly addressed.
"Additionally, procedures that outline the required documentation of results from investigation or replies to complainants are imperative to ensure that complaints were thoroughly addressed and accepted by both the complainants and your firm," the letter says.
FDA inspectors also uncovered the firm’s failure to document all corrective and preventive action activities and their results, a failure to provide sufficient documentation of the design review meeting minutes in the Design History File and a lack of procedures for quality audits.
Euro Diagnostica did not respond to a request for comment.