Comprehensive Gap Analyses for 503A Sterile Compounding Facilities

Client Type:

Sterile 503A compounding pharmacies, including hospital-based sterile Category 1 facilities and complex nonsterile-to-sterile Category 2 and 3 operations

Engagement Summary:

Restore Health Consulting provides end-to-end gap analyses for sterile compounding facilities preparing for NABP, State Board, or internal quality inspections. With over 100 projects completed nationwide in a 5 year timespan, our team brings unmatched clarity, compliance insight, and operational foresight to each facility we assess.

The Challenge

503A sterile compounders face increasing scrutiny from state boards of pharmacy inspectors, NABP and/or PCAB surveyors, and sometimes even FDA safety officers. Many facilities lack the internal bandwidth or regulatory expertise to critically assess whether their SOPs, workflows, and contamination control strategies meet evolving expectations.

Compounding this risk: failing an audit can result in operational shutdowns, reputational damage, and significant remediation costs.

Our Solution: A Proven Four-Phase Audit Methodology

1. Pre-Audit Preparation

  • Reviewed facility-specific SOPs and risk points

  • Developed a customized audit checklist tailored to facility type (Category 1, 2, or 3)

  • Planned and aligned with site leadership on goals, timelines, and logistics

2. On-Site Audit Execution

  • Conducted a comprehensive walkthrough and documentation review

  • Evaluated compliance with USP <797>, <800>, state-specific regs, and facility-specific protocols

  • Hosted daily debriefs and a final close-out meeting to deliver real-time insight

3. Audit Report Delivery

  • Compiled all findings into a structured, prioritized report

  • Provided actionable recommendations to correct, enhance, or streamline

  • Ensured the report was review-ready for internal leadership or external auditors

4. Post-Audit Support

  • Addressed follow-up questions and reviewed client remediation plans

  • Assisted with response drafting and documentation improvements

  • Supported implementation and provided additional training, when needed

The Result

✔ Clear, prioritized roadmap to compliance tailored to each client’s compounding type and regulatory jurisdiction
✔ Avoided inspection findings and reduced risk of enforcement action
✔ Strengthened internal quality systems, staff readiness, and documentation practices
✔ Clients were able to pass NABP and State Board inspections confidently and efficiently

“Restore Health’s gap analysis wasn’t just a compliance checklist—it was a full operational tune-up. We felt confident going into our next audit because we knew exactly where we stood and what to fix.”

Services Delivered

  • Customized Audit Checklists

  • Full-Scope Facility Gap Analysis

  • USP <797>/<800> and State-Specific Compliance Reviews

  • Staff Readiness Support and SOP Optimization

  • Post-Audit Remediation & Advisory

Planning for a board inspection or internal quality review?

Let Restore Health Consulting guide your 503A facility with a proactive, expert-led gap analysis that sets the foundation for compliance, safety, and operational success.