Be prepared for your next inspection.
Inspection readiness assessments for pharmacies and drug distributors
Your policies may be current—but do they reflect what happens in your facility every day?
HVRS Solutions helps pharmacies and drug distributors identify regulatory and operational gaps before an inspection. We review your documentation, discuss your processes with your team, and evaluate whether your practices and records support your written procedures.
A practical review of your facility
Each assessment is tailored to your business, the services you provide, and the inspection requirements you need to prepare for.
For pharmacies, the review may include:
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Sterile and nonsterile compounding practices
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Personnel training and competency documentation
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Quality assurance, monitoring, and corrective actions
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Policies, procedures, and supporting records
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Medication storage, handling, and hazardous drug practices
For drug distributors, the review may include:
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Licensing and designated representative requirements
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Supplier and customer qualification
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Receiving, storage, shipping, and temperature controls
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Transaction records and DSCSA procedures, as applicable
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Returns, recalls, complaints, and suspect product procedures
What you receive
You’ll receive a written findings report identifying the gaps observed, why they matter, and recommended corrective actions. We prioritize the findings so you can focus your time and resources where they are most needed.
We’ll also meet with your team to discuss the results, answer questions, and walk through the recommended next steps.
Remote reviews and on-site mock inspections
A remote assessment can help identify gaps in policies, records, and documented processes. An on-site mock inspection adds direct observation of your facility and staff practices.
We’ll recommend an approach based on your needs—whether you’re preparing for an initial inspection, introducing a new service, or checking the readiness of an established operation.
Experience on both sides of an inspection
HVRS Solutions brings pharmacy operations, regulatory consulting, and inspection experience to the review. Our goal is to help your team understand what needs attention and how to address it.
If you need help implementing the recommendations, we can provide a separate proposal for remediation support.
Let’s discuss your facility.
Tell us about your operation, the inspection you’re preparing for, and your timeline. We’ll recommend a scope and provide a customized quote.