King Systems – owned by Ambu A/S – has received a Warning Letter from the U. S. Food and Drug Administration (FDA) relating to an inspection of the King Systems manufacturing site in Noblesville, USA. The Warning Letter references King Systems’ reply to the inspectional observations left by the FDA at the conclusion of the inspection.
The Warning Letter primarily addresses the timeline for validation of manufacturing processes for some legacy products. All new products and processes launched in the past 2.5 years have been validated, so this observation applies to retroactively validating the legacy processes. The Warning Letter is not expected to have consequences for products on the US market and little, if any, in other markets.
King Systems and Ambu take the request from FDA very seriously and has replied to FDA’s Warning Letter on October 21, 2013. This is part of the efforts to bring the aforementioned processes to a higher standard than ever before.
Contact
Lars Marcher, President & CEO, tel. +45 5136 2490, email: lm@ambu.com
Ambu A/S
Baltorpbakken 13
DK-2750 Ballerup
Tel. +45 7225 2000
CVR no.: 63 64 49 19
www.ambu.com
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