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# Sterile PRP Separation Kit Sold Illegally: FDA
- URL: https://www.fdaweb.com/sterile-prp-separation-kit-sold-illegally-fda/
- Published: 2018-01-31T12:00:00.000Z
- Updated: 2026-09-14T23:18:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140648

FDA says that Physicians Products Inc. is selling its Sterile PRP Separation Kit online in violation of the Federal Food, Drug, and Cosmetic Act since it does not have a PMA approval or IDE in effect. “On your Web site, you market the product as ‘FDA approved,’ and offer it for sale in U.S. dollars to buyers throughout the United States,” the agency’s 1/26 [letter](https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/UCM594578.pdf?ref=fdaweb.com) to the manufacturer says. “Because you do not have marketing approval or clearance from FDA for the Sterile PRP Separation Kit used with or without the centrifuge you also offer for sale on your Web site, marketing this product in the United States appears to be in violation of the Act.”