483
Connectronics SROFDA 483 - Connectronics SRO - February 06, 2020
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Record Details
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.
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ID · 4547292d-8039-4d03-859c-4f4f73f985d1