Inspections, Compliance, Enforcement, and Criminal Investigations
Millipore Corporation Closeout Letter 2/17/10
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
February 17, 2010
We have received your January 12, 2010 and February 2, 2010, email responses to the December 29, 2009, Warning Letter issued by CDRH, OIVD. We have reviewed the corrections that you have made to your web site relating to your marketing and sale of the following medical devices: Light Diagnostics brand respiratory screens and panels and the SimulFluor Flu A/B typing kit. Your corrective actions appear to adequately address the concerns detailed in the Warning Letter. We will periodically monitor your web site to insure your continued compliance. You are reminded that it is your obligation to ensure that all of the medical devices that you market and sell on your web site comply with the Federal, Food, Drug & Cosmetic Act.
Your emails also requested that your responses be posted on FDA's website. According to our FOIA office, the WL response pilot program was discontinued and we are not posting WL responses. I will however notify the Flu Taskforce that your response is acceptable and they will indicate that your website does not include fraudulent H1N1 claims. The information can be found at http://accessdata-test.fda.gov/scripts/h1n1flu/.
Biologist/Consumer Safety Officer
Office of In Vitro Diagnostic Device
Evaluation and Safety
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993