Our QAS Inspection​ program covers facilities with business models including, but not limited to, the following:

• Prescription drug manufacturers (distribution activities only, not cGMP)

• Virtual manufacturers (distribution activities only, not cGMP)

• 503B Outsourcing facilities (distribution activities only, not cGMP)

• Prescription drug wholesalers

• Medical Gas Distributors (distribution activities only, not cGMP) 

• Reverse Distributors

• Drug Repositories

• Specialty wholesalers

• Virtual wholesale distributors

• OTC wholesalers

• OTC-only wholesalers

• Medical device wholesalers

• Veterinary wholesalers

• Third-party logistics (3PL) providers (for prescription products, OTC and OTC only, medical devices, veterinary, etc.)

• Facility submits Pre-Inspection Application and attaches the requested information and documentation. 

• NCDQS will review materials before reaching out to schedule an Intake Call.

• NCDQS and Applicant will have an Intake Call.

• NCDQS will perform the Inspection, and inspector will review any partially compliant or non compliant findings with the facility.

• A Remediation plan will be created as appropriate.

• NCDQS will provide the Inspection Report to Applicant. NCDQS will provide Inspection Reports to state agencies directly, if requested by Applicant. 

• Inspections are unannounced (i.e. not scheduled with the facility). Note: A window of one or two weeks may be provided, the inspection will still be unannounced within this window.

  • Inspections for virtual entities that do not take possession of product will be announced and scheduled due to the remote nature of their business.

• We are typically able to perform an inspection between 4 and 8 weeks from accepting the application and holding the Intake Call.

• Inspections are performed during normal hours of operation.

• Reports are reviewed at the end of the inspection, and received by the facility within 1 week of being inspected.

• Pre-Inspection Application submission flat fee: $4,000*   *

• NCDQS inspector travel expenses are already included in the flat fee. 

• *Additional fees may be incurred for deviations in Inspection process including, but not limited to, additional site visits, or facilities located in Hawaii or Alaska.

• **Inspection Fee is non-refundable unless site visit is not performed. If site-visit is not performed, Applicant will be refunded $2,000 site visit fees.

• Colorado

• Iowa*

• Kansas

• Maryland

• Mississippi

• Nebraska

• New Hampshire

• South Carolina

• South Dakota

• Tennessee *Out of state 3PL require accreditation

• Utah

• Vermont

• Washington

• Wyoming*

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Additional states have informally accepted QAS Inspection reports.

*Accreditation may be required.