The 4 Steps of an Effective Mock FDA Inspection

Inspections by the Food and Drug Administration can be challenging.

If the company fails, the FDA can issue them a warning letter or, in extreme cases, shut down the company’s operations entirely.

Because the consequences of noncompliance are serious, many executives would like to know where the issues lie beforehand.

As such, they may choose to consult with an outside firm to conduct a mock inspection. These inspections can help identify any issues that the executive might have beforehand regarding compliance with the FDA regulations.

They are a useful tool for helping the executive to determine the gaps in compliance with the Food and Drug Administration regulations.


4 Steps of a Mock FDA Inspection

A mock inspection occurs over four days and is conducted in the same manner as a real inspection by the Food and Drug Administration.

In general, it consists of a consultant reviewing records, interviewing appropriate employees, and conducting meetings to update the executive on the status of the inspection.

1. Day One: Meeting to discuss the logistics of the inspection and tour of your facility

On Day 1, the consultant will arrive and present the letter regarding the inspection. He or she will then conduct a meeting regarding the overall logistics of the inspection and tour the facility. Afterward, the consultant will meet with the compliance departments at the company, including regulatory affairs and quality assurance.

He or she will schedule and conduct interviews with the appropriate quality assurance personnel (and regulatory affairs personnel, if time allows). The consultant will also review standard operating procedures, training records, trial master files, and the results of internal audits. At the end of the day, the consultant will meet to discuss the progress of the inspection and schedule interviews for the next day.

2. Day Two: Review of management controls and procedures

The consultant will spend the early part of Day 2 reviewing retention records and policies, such as the schedules for retaining and archiving data. He or she will review management controls and procedures regarding the integrity of electronic data.

He or she will also interview the personnel who are scheduled for an interview. During the afternoon, the consultant will review product controls at the site. These include procedures for labelling and manufacturing the products; receipt, preparation, and storage of raw materials; and annual product reviews. He or she will meet to discuss how the inspection is progressing, answer questions, and request interviews for Day 3.

3. Day Three: Pre-Interviews, review and evaluation

At the beginning of Day 3, the consultant will interview personnel identified at the meeting on the previous day. The subject matter of these interviews will include corrective action and prevention plans, handling of complaints, and oversight of suppliers.

During the afternoon, he or she will review supplier controls at the site, which include evaluating suppliers and reviewing their qualifications, reviewing suppliers’ contractual controls, and overseeing and managing suppliers. He or she will meet at the end of the day to discuss the progress of the inspection, answer questions, and request to interview certain personnel on Day 4.

4. Day Four: Interviews, exit meeting, and next steps

During the morning on the last day of the inspection, he or she will review any outstanding compliance sections and conduct interviews of personnel identified during the meeting on Day 3.

The consultant will spend the afternoon interviewing any remaining personnel and clarify any questions or issues that arose earlier.

After wrapping up, the consultant will conduct an exit meeting. During this meeting, the consultant will review major and minor findings, discuss strategies to fix the issues, answer questions, and discuss the next steps.


Mock inspections for pharmaceuticals serve a useful tool to executives. Through these inspections, executives can identify issues in compliance and familiarize themselves with what to expect.

As a result, these mock inspections can better prepare executives for actual inspections and avoid disciplinary actions by the Food and Drug Administration.

Want to learn more about mock FDA inspections and how an FDA consultant can help you prepare for a real-life inspection? Grab our free whitepaper: The Benefits for Pharma Companies of Working with an FDA Compliance Consulting Firm.

Topics: Process, FDA Warning Letters, Regulations, Quality Standards, FDA Auditing, FDA regulatory consultants, Global Regulations