Mock-Up FDA Audits

Our ALP Sourcing lead consultant has knowledge of the United States Federal Food, Drug, and Cosmetic Act (FD&C Act) and related laws, regulations and policy through various positions, training, and experiences. He started United States Federal Food and Drug Administration (US FDA) field office as a Chemist, then FDA Field Office Medical Device Investigator, Compliance Officer, national authority in unapproved new drugs, foreign inspection cadre, and as a Supervisory Investigator, he supervised Medical Device and Drug Investigators.

Let someone with a background at the FDA help you. If your consultant has never worked for FDA, then he or she may not be in position to perform mock-up FDA audits. Our lead consultant has a total of 30 years with FDA inspections, combining 16 years at the FDA itself and 14 years of mock FDA audits.

    Vendor Audits by exFDA

    When conducting mock-up FDA audits for a medical device manufacturer, our consultant will follow Guide to Inspections of Quality Systems (QSIT) technique, covering the following subsystems

    • Design Controls
    • Corrective and Preventive Actions (CAPA)
    • Production and Process Controls (P&PC)
    • Facility & Equipment Controls
    • Material Controls
    • Records, Documents Change Control
    • Plus Medical Reporting Regulations (MDR), Reports of Corrections and Removals, and Medical Device Tracking.

    The QSIT technique for performing mock-up FDA audits is based on a “top-down” approach to provide you the key objectives that can determine your state of compliance. You will not get any more “real world” mock-up FDA audits.

    As a guide to mock-up FDA audits of drug manufacturers to determine the compliance with the drug CGMPR’s, our inspection is based on IOM (Investigations Operations Manual), for example:

    • Bulk Pharmaceutical and Raw Materials
    • WFI and High Purify Water Systems
    • Cleanroom Validation
    • Process Validation
    • Sterilization Validation
    • Computer and Software Validations
    • Cleanroom Validation
    • Cleaning Process
    • Environmental Monitoring
    • Lyophilization Process
    • Media Fills
    • Quality Control and Microbiological Laboratories
    • DMR and DHR Batch Review
    Mock FDA Inspection by exFDA