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CLOSEOUT LETTER

Rapid Diagnostics, Division Of Mp Biomedicals, Llc May 13, 2016

Rapid Diagnostics, Division of Mp Biomedicals, Llc - Close Out Letter 5/13/16


Rapid Diagnostics, Division Of Mp Biomedicals, Llc

  

Department of Health and Human Services' logoDepartment of Health and Human Services

 
 San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
Telephone: 510-337-5700

May 13, 2016

VIA USPS

Milan Panic, CEO
Rapid Diagnostics, Division of MP Biomedicals, Llc
1429 Rollins Road
Burlingame, CA 94010-2316

Dear Mr. Panic:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 460425 dated August 24, 2015. Based on our evaluation, it appears that you have addressed the violations 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.

Sincerely,

/S/

Director of Compliance
San Francisco District