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FDA Flags Violations at Medical Device Firms in Sweden, Canada, Spain, UK

Posted 30 October 2018 | By Ana Mulero 

FDA Flags Violations at Medical Device Firms in Sweden, Canada, Spain, UK

Device firms in Sweden, Canada, Spain and the UK separately drew four US Food and Drug Administration (FDA) warning letters over good manufacturing practice (GMP) violations.
The GMP violations cited in the warning letters posted Tuesday stem from inspectional
observations first noted in FDA Form 483s issued to each of the four device manufacturing facilities, following the site visits investigators conducted during 2017 and 2018.
Most of the firms issued response letters for the agency to review proposed corrective and preventive actions (CAPAs). The majority of the issues cited in the 483s to these firms became violations for inadequate responses, with the exception of an incomplete response from Spain-based Leventon S.A.U. over a failure to submit timely adverse event reports. The warning letter issued to Canada-based Cardiomed Supplies does not refer to a response letter. 
Swedish firm Boule Medical AB had a total of six violations cited in its warning letter, followed by Leventon S.A.U. and UK-based Gaeltec Devices LTD with five violations each and Cardiomed Supplies with three violations. Most of the violations across all four warning letters are associated with inadequacy in validation activities, procedures for implementing CAPAs, maintaining device history records (DHRs) and handling customer complaints.
The agency said it has temporarily placed the adulterated and/or misbranded class III devices manufactured by three of the four firms in “detention without physical examination” to prevent these from entering the US “given the serious nature of the violations.” These include Gaeltec, Leventon and Cardiomed Supplies. Gaeltec’s Catheter Tip Pressure Transducers were deemed misbranded over changes the firm previously implemented without the required FDA approvals.
Boule’s situation is unique in the batch in that its warning letter is the only one from the Office of In Vitro Diagnostics and Radiological Health (OIR) at FDA’s Center for Devices and Radiological Health (CDRH), rather than CDRH’s Office of Compliance. It also showcases new enforcement activity regarding compliance to device labeling requirements on unique device identifiers (UDIs).
DHR violations in the warning letter to Boule, which manufacturers class II devices, cite a failure to refer to or include the location of sub-assemblies based on an FDA review of DHRs from April 2017 to April 2018. “Some of the reviewed DHRs were also missing the required UDI labels,” wrote OIR Director Timothy Stenzel.
UDI compliance deadlines range from September 2014 to 2020 depending on device type and intended use for requirements on labeling, direct marking and submitting data to the Global UDI Database. Device-led combination products were recently added to the list of delayed compliance deadlines for submitting UDI data. Delays have been attributed to adoption issues at the manufacturer level over the course of the phased-in implementation.


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