503B Outsourcing Facility Opens With Zero FDA 483s—A Rare Success

Client Type

Newly registered 503B outsourcing facility preparing for its initial FDA inspection

Engagement Summary

Restore Health Consulting was brought in to conduct a pre-inspection audit readiness assessment shortly before the client’s first FDA audit. Knowing that nearly all 503B facilities receive multiple FDA Form 483 observations at opening, the client aimed to be among the few to pass without issue—and turned to Restore for expert guidance.

The Challenge

FDA inspections for newly registered 503B facilities are exceptionally rigorous, particularly given the agency’s focus on sterile compounding, aseptic process validation, and GMP compliance. Most 503B facilities receive 483s during their first inspection—often for issues related to environmental monitoring, procedural controls, documentation practices, and contamination risk.

The client wanted to minimize inspection risk and avoid delays in becoming operational—but lacked full confidence that internal teams could catch every detail before the FDA arrived.

Our Solution

Restore Health Consulting performed a full-scope audit readiness engagement, including:

  • Facility-Wide Walkthrough
    Evaluated classified areas, gowning flows, material and personnel paths, and aseptic operations against CGMP and FDA expectations

  • SOP and Documentation Review
    Assessed critical procedures, validation packages, batch records, EM data, and deviation handling for compliance and inspection-readiness

  • Observation and Action Plan Delivery
    Provided a clear list of remediation actions with prioritization, regulatory rationale, and implementation guidance

  • Staff Readiness Coaching
    Helped key staff prepare for inspection dialogue and documentation presentation

The Result

✔ All identified gaps were remediated prior to the FDA’s arrival
✔ The FDA conducted its full inspection—and issued zero 483 observations
✔ The facility became fully operational without delay, penalty, or remediation timeline
✔ The client joined a very small group of 503Bs to open their doors with a clean FDA report

“Restore helped us get there. Their knowledge of what FDA looks for, and how they look for it, made all the difference.”

Services Delivered

  • 503B Audit Readiness Assessment

  • SOP, EM, and Validation Package Review

  • CGMP Compliance Evaluation

  • Remediation Planning

  • Inspection Coaching and Staff Support

Preparing for an FDA inspection?

Let Restore Health Consulting help you identify and fix issues before regulators do—with a proven track record that includes 503Bs opening with zero 483s.