Florida's specialist consultancy for USP <797> and <800> compliance, cleanroom certification, and sterile compounding staffing. We make your facility audit-ready, year-round.
Five categories that close pharmacies. We resolve each one before your next inspection.
Unannounced state inspections expose documentation gaps, room pressure failures, and SOP deficiencies that trigger immediate corrective actions.
Average citation fine
Fines, probation, or permit suspension — per violation
How we solve this
We keep your cleanroom inspection-ready 365 days a year, with documentation current, logs complete, and protocols audit-proof.
USP <797> 2023 revisions introduced sweeping changes. Facilities still running legacy procedures face citation risk with every inspection cycle.
Cost of a failed re-inspection
$25,000 – $75,000 in remediation fees
How we solve this
We audit your existing SOPs and align them with current USP <797>/<800> standards so you're never caught with outdated policies.
Missed viable and non-viable particle counts, inadequate surface sampling, or failed trending analysis invalidates your cleanroom certification.
Cleanroom recertification cost
$8,000 – $30,000 + 2–4 weeks downtime
How we solve this
Our EM programs are fully documented and trend-tracked, so your certification stays valid and your data tells a clean story.
Unqualified or under-trained compounding personnel are among the top cited violations in Florida Board of Pharmacy inspections.
Cost of a personnel-related closure
Every day closed is revenue your facility won't recover
How we solve this
We supply trained, experienced sterile compounding technicians ready to integrate without disrupting your operations.
Navigating FDA outsourcing facility registration, CGMP requirements, and state board licensing simultaneously overwhelms most pharmacy teams.
Average FDA warning letter response cost
FDA warning letter response can reach six figures in legal and remediation fees
How we solve this
We've guided facilities through both 503A and 503B pathways and can map out exactly what your facility needs to get there.
Comprehensive programs designed to achieve, maintain, and document USP compliance at every level of your operation.
Full-scope USP <797> and <800> compliance program for ISO-classified cleanrooms. We audit, remediate, certify, and maintain your facility's compliance posture year-round.
Credentialed sterile compounding pharmacists and pharmacy technicians placed on-demand. Short-term coverage, long-term contracts, or urgent gap-filling. All pre-vetted for USP competency.
Strategic guidance through Florida Board of Pharmacy interactions, 503A/503B designation pathways, FDA CGMP readiness, and DSCSA compliance for outsourcing facilities.
We audit your facility against current USP <797>/<800> standards and identify every gap.
A prioritized remediation roadmap is delivered within 5 business days.
Our team implements fixes (SOPs, certifications, staffing) on your timeline.
Ongoing monitoring, annual reviews, and pre-inspection readiness keep you compliant.
Every engagement is led by pharmacists and PTCB-certified technicians with hands-on sterile compounding experience. Not generalist consultants reading from a checklist. We work inside your facility, alongside your team, until compliance is no longer a concern.
Talk to our compliance teamElite-Level Sterile Support for Critical Environments.
Check the items that apply to your cleanroom. Takes 30 seconds.
You're well-positioned. Let's make sure it stays that way.
Schedule a Maintenance Review →You have some exposure. A gap assessment would catch it early.
Request a Free Assessment →Your facility has significant compliance risk. Don't wait for an inspection to find out.
Talk to a Specialist Today →Schedule a free 30-minute assessment with one of our USP compliance specialists.