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FDA 483, CD, CIA

483, Consent Decrees, and Corporate Integrity Agreements
American Medical Systems: Minnetonka, MN
  • Assisted in the Regulatory Affairs review of the changes found during remediation. 
  • Submitted a PMA supplement due to a change required for remediation. 

Fresenius Medical Care NA: Waltham, MA
  • Worked with the staff at Keysville, UT to ensure that the documentation for a pending 510(k) met the requirements laid out in the letter to the Ogden plant.

Spectranetics: Colorado Springs, CO
  • Worked on the document review committee to ensure that any documentation issues from Spectranetics met the requirements of their Corporate Integrity Agreement.

GE Healthcare: Lawrence, MA & Salt Lake City, UT
  • Worked on gathering information from the SLC and Lawrence sites to correct errors found in the technical files after the Consent Decree stopped all shipping for a year.
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