FDA WARNING_LETTER - Stihler, Alex - December 13, 2007

During an FDA inspection of Stihler Electronics GmbH in Stuttgart, Germany, from December 10-13, 2007, it was determined that their Astoflo Plus device is adulterated and misbranded. The Astoflo Plus is adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE). It is also misbranded under section 502(o) because the firm failed to notify the FDA of its intent to commercially distribute the device, as required by section 510(k) of the Act.

The FDA requires prompt corrective action. Failure to comply may result in device detention upon entry into the U.S., federal agencies being advised of the Warning Letter for contract considerations, and denial of PMA applications or Certificates to Foreign Governments until violations are corrected.

Stihler Electronics must respond in writing within fifteen working days, detailing specific corrective steps, prevention plans, and a timetable for implementation. The firm also needs to update FDA listing records to reflect its role as a distributor, not a manufacturer, and create listings for Astotherm IFT+ Astotube and SpectraTherm if exported to the U.S. Additionally, if the Prismaflo II is exported, a new 510(k) is required due to design changes.