A Basic Guide to Mock FDA Audits

Mock FDA audits are an essential tool in identifying issues that could affect the quality of manufactured pharmaceuticals or medical devices, and become compliance issues with FDA.

As such, pharmaceutical and medical device executives should understand what a mock FDA audit is, why they should arrange for a mock FDA audit to be conducted, and what a standard mock FDA audit entails.

What is a Mock FDA Audit?

Mock audits are simulations of actual FDA audits conducted to assess Good Clinical Practice, Good Laboratory Practices, and Good Manufacturing Practices.

They can be performed by:

  • An internal team using FDA procedures, or
  • An external team of ex-FDA employees

An internal team consists of qualified professionals with experience in regulatory compliance. If an external team is used, it generally consists of members of an outside consulting firm with FDA work experience.

Personnel who work for this external firm are experienced in conducting audits on a variety of companies and pharmaceutical products for the FDA.

Because they are less biased than an internal team might be, they can offer objective insight into deficiencies of compliance with FDA regulations.

Regardless of whether an internal auditor or an external auditor is selected, the auditor should thoroughly understand the manufacturing process and controls; the development, quality control, and validation of products and processes; the process for incorporating changes; applicable quality assurance processes; and human relations as it pertains to audits.

Auditors should also have the support of personnel in upper management.

Why Conduct a Mock FDA Audit?

Mock audits can help pharmaceutical and medical device executives do three things:

  1. Determine what FDA inspectors are looking for during an actual audit
  2. Prepare for an actual FDA audit, and
  3. Identify common issues of compliance and learn how to rectify them

Pharmaceutical and medical device companies can use mock FDA audits to prepare for upcoming inspections by the FDA, which can also cover requirements of the European Medications Agency, or Health Canada and to determine cost-effective frameworks for complying with 21 Code of Regulations.

Pharmaceutical and medical device companies can also use mock FDA audits to become certified in ISO and become ready for a preapproval inspection. Mock FDA audits can also be used to qualify critical suppliers and to determine a where a company initially stands regarding compliance.

Pharmaceutical and medical device companies can then use this information to for improve operations. If they use an external audit team, they can use the information provided as a basis for performing self-audits.

How Can You Apply the Results of a Mock FDA Audit?

With the information provided by mock FDA audits, pharmaceutical and medical device companies can:

  • Obtain evidence that management is overseeing operations effectively
  • Review the compliance of contract service providers
  • Verify that quality assurance and regulatory affairs departments are operating appropriately
  • Evaluate process controls, records, and document controls; and
  • Determine whether the mechanisms are compliant

The evidence of compliance can then be shown to clients. Identification of areas that can be improved during the coming year can also be a reason for conducting a mock FDA audit.

Mock FDA audits also help to prepare personnel psychologically so that they are calm during an actual audit. As such, it is advantageous for pharmaceutical companies to arrange for a mock audit to be conducted.

Typical Format of a Mock Audit

A mock audit is usually conducted over four to five days and utilizes FDA inspection procedures. At the end of each day, the auditor provides a recap of findings at a closing meeting and identifies personnel to interview.

On each subsequent day, the auditor interviews any personnel that he or she identified on the previous day. The general format is as follows:

  • Day One: The mock FDA auditor meets with people from the company, tours the facilities, and reviews the internal quality files.
  • Day Two: the mock FDA auditor reviews the policy for retaining records and product controls at the facilities.
  • Day Three: the mock FDA auditor reviews procedures for corrective action plans, the handling of complaints, and the oversight of suppliers.
  • Day Four: the mock FDA auditor reviews any remaining compliance programs and interviews any personnel that he or she still needs to interview.
  • Day Five (if needed): additional areas of the quality systems not previously covered will be reviewed.

On the end of the fourth or fifth day, the mock FDA auditor conducts an exit meeting with the company. During this meeting, the mock auditor provides a review of major and minor findings and suggests actions to improve the issues that he or she found.


Mock FDA audits are important for the identification of gaps in the quality systems related to pharmaceutical or medical device manufacturing.

By understanding what they entail, pharmaceutical or medical device companies can better prepare for real audits by the Food and Drug Administration. Conducting mock audits can also enable manufacturers to improve their systems and increase the quality of their products.

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Topics: Process, FDA Auditing, FDA regulatory consultants, Compliance Consulting