FDA Inspection Audit Support

GxP Audits / Remote or Onsite / Inspection Readiness / Mock FDA Audit / GAP Analysis / Validation

FDA Audit Support Services
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A Proactive Quality Management System

Surviving an FDA inspection is all about managing risk and knowing what is important to the FDA.

Premier FDA Solutions knows the importance of fostering a culture of quality as the FDA is continuing to prioritize a Proactive Quality Management System. Recognizing this and also knowing that every company’s needs are unique, we have a range of right-sized FDA audit support services to meet your needs, whether you are in need of a comprehensive corporate quality management system audit or a focused site audit. Our thorough, attentive FDA audit support services help you reduce FDA inspection risks while you continue to focus on your business objectives.

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GxP Audit Support

The preparation you need for a successful FDA audit

cGMP Regulations
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Validation / Qualification Activities:

  • Evaluate the adequacy of products, equipment, and facilities
  • Validation/qualification of policies, procedures, protocols, and master plans
  • Validating/qualifying electronic records; manufacturing, packaging, and labeling processes; cleaning, sterilization systems and processes; and facilities, utilities, and equipment
  • Computer Systems Validation and 21CFR Part 11 Compliance
Validation & Qualification
FDA Inspection

Other Inspection Related Activities:

  • Internal audits or GAP assessments of the Quality Management System
  • Vendor and Supplier audits
  • GDP audits
  • Due Diligence

Audits Include the Following Customizable Components

  • A pre-audit kickoff call outlining client objectives and daily agenda for the audit, including customized audit approach:

    • Formal FDA Audit, “Hats-on, Hats-off” Audit, deep dive into specific area, high level “checkup”, etc.
  • Onsite or remote audit with guidance before and during the inspection
  • An initial summary of the overall audit findings at the close of the onsite visit
  • A detailed, written audit report outlining Observations & Deficiencies (categorizing by criticality)
  • A risk-based Corrective Action Plan (Premier FDA Solutions can also assist with any needed post-audit remediation of documents and Quality System GAPs.)
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Contact Us Now for a Same Day Response and Get FDA Ready!

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(262) 372-3039