In the USA, sunbeds and solariums are classified as medical devices, meaning that they are subject to FDA testing. JK-Ergoline/JK-Holding GmbH has now been successfully inspected for the second time in this context.
The regular inspection of JK-Ergoline/JK-Holding GmbH by the FDA (Food and Drug Administration; an authority that reports to the US Department of Health and Human Services) took place in mid-September. The FDA inspects manufacturers whose products fall under the FDA's regulatory requirements every two years. This inspection goes far beyond other procedures, such as ISO 9001 certification. The FDA's task is not only to scrutinize the plausibility of the organizational or operational processes described, but also to focus its inspection on uncovering errors in the system. Failure to pass the FDA inspection can result in severe penalties, depending on the severity of the deviations, ranging from a warning letter to a ban on importing the products in question into the USA.
JK-Ergoline/JK-Holding GmbH is a company that is very export-oriented. The most important sales market outside Germany is the USA. It is therefore fair to say that not only was a "super-GAU" prevented here, but a major success was achieved.
Complex inspection
Two rooms were needed for the inspection, which took about a full week: The FDA inspector sat in the front office with a recording clerk and employees from Ergoline's QM department. In the back office, 14 employees with access to high-speed computers were waiting for information on which documentation and records were to be submitted via a "request card". These then had to be submitted to the FDA inspector within a very short time. The aim of the inspection is to provide evidence that the FDA's regulatory requirements are being met.
Everything perfect and error-free
After a week, it was clear: JK-Ergoline/JK-Holding GmbH can be certified as working perfectly in accordance with FDA specifications. Head of QM Lars Quadt and Sales Manager Hans-Dieter Roggendorf were delighted with the excellent result, which once again proves the high standard at which JK-Ergoline/JK-Holding GmbH works.
You can also buy new and used Ergoline sunbeds at fitnessmarkt.de!
Source: F&G
Published on: 8 January 2019