The FDA issued a warning letter to Euro-Diagnostica in Malmo, Sweden for its complaint and CAPA procedures as well as its quality audits, and said the company’s responses to observations from a January inspection were inadequate.
The agency issued a Form 483 following an inspection of Euro-Diagnostica’s facility, noting the company’s complaint procedures did not ensure complaints were handled in a timely manner or were properly evaluated for medical device reportability. The company’s response was deemed inadequate because it did not include evidence the firm had established procedures for timely to address complaints in a timely way.
In addition, the company failed to provide evidence that its CAPA procedures recorded and documented all activities required under 21 CFR 820.100(b). The agency further faulted the company’s procedures for design reviews, as it did not adequately document the independent review involved in design for a product or provide evidence of systemic corrective action.
The company had also not adequately identified gaps in its design control or documentation that it took systemic corrective action to confirm correlation testing took place for all products that were subject to design changes.
The company failed to properly document an audit of its quality systems, and failed to include correction and removal actions in its action plan in response to two customer complaints it received in July and September of 2015.
Read the full warning letter here: www.fdanews.com/10-13-17-EuroDiagnosticaWL.pdf. — Zack Budryk