FDA 483 - Connectronics SRO - February 06, 2020

Connectronics SRO, a medical device manufacturer in Kladno, Czech Republic, was inspected by the FDA from February 3-6, 2020. The inspection revealed significant deficiencies in quality system procedures, including inadequate control of non-conforming products, insufficient device history records, and the use of unapproved and obsolete documents. These issues indicate a moderate level of non-compliance with quality system regulations.