FDA 483 - Tec Com Gmbh - August 23, 2018

Tec Com Gmbh, a medical device manufacturer, was cited for two significant observations during an FDA inspection. The firm failed to report a recall of temperature-regulating medical devices with faulty heating elements to the FDA, despite five devices being in the US market. Additionally, their sampling plans for incoming inspection of critical outsourced components lacked valid statistical rationale, indicating deficiencies in their quality system and regulatory compliance.