Sterile 503A Pharmacy in California Achieves Inspection Readiness and Smooth M&A Exit
Client Profile
A 503A compounding pharmacy in California specializing in sterile preparations, including batch production from nonsterile starting materials (high-risk activities under CA Board of Pharmacy oversight).
The Challenge
California’s pharmacy regulations around sterile compounding are among the most stringent in the country. The client was preparing for both their annual state inspection and an anticipated M&A transaction in the next 12–18 months. They needed expert insight to proactively identify and correct gaps before either event could jeopardize operations or valuation.
Our Solution
Restore Health Consulting conducted a comprehensive, onsite gap analysis and facility walkthrough, focused on:
Compliance with California Board of Pharmacy regulations and USP <795>/<797>/<800>
Risk-based review of batch compounding from nonsterile materials
Evaluation of documentation, environmental monitoring, quality assurance, and aseptic practices
Actionable report with prioritized remediation recommendations
Direct support in implementing corrective actions
The Outcome
✔ The client passed their annual California Board of Pharmacy inspection with zero findings
✔ The M&A transaction closed the following year with no regulatory delays or valuation setbacks
✔ The pharmacy was positioned as a well-run, compliant operation attractive to buyers and regulators alike
Client Impact
With expert guidance and early remediation, the client eliminated compliance risk ahead of both regulatory and business milestones—ensuring operational continuity and maximizing deal value.