REU Associates

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Office: 440.953.9789
Fax:     440.953.9789
Cell:     440.840.0949


  • Processed Based Auditing
  • Warning Letter
  • ISO 13485:2003
  • EN MDD/93/42/EEC

Do you know if you are prepared for an FDA audit?
Are you confident that your suppliers/contractors are meeting their obligations? Are your internal processes being followed?

Many organizations do not have the time or experience to conduct audits. Many do not understand how to handle a FDA inspection. Our consultants are experienced in leading audits and managing audits from regulatory agencies and standards organizations.

Our auditing services:

  • Help you prepare for an FDA Inspection
  • Develop your internal and supplier program
  • Will serve as your Internal Audit staff (contracted)
  • Conduct Gap Analysis
  • Manage your ISO certificate audits
  • Conduct follow-up audits to Corrective Actions for Warning Letter improvements
  • Are conducted in accordance with MDD, ISO 13485,and QSRs
  • Will conduct Supplier/Contractor audits. We give you confidence that your suppliers are meeting their commitments.


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