Sanmina SCI AB - Close Out Letter 8/7/14
- Sanmina SCI AB
Department of Health and Human Services
|Food and Drug Administration|
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
August 7, 2014
Mr. Tim McGinnis
Vice President RA/QA
Sanmina SCI AB
SJALEVAD, ORNSKOLDSVIK SE891 23 SWEDEN
Dear Mr. McGinnis:
The Food and Drug Administration has completed an evaluation of your firm's corrections and corrective actions in response to our Warning Letter (CMS case # 423189) dated April 11, 2014. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Office of In Vitro Diagnostics and
Center for Devices and Radiological Health