Mock FDA Inspection by Ex-FDA Investigators

Consider conducting a mock FDA inspection with your staff to prevent a catastrophic event. This proactive measure can help you identify gaps and close them before they become 483 deficiencies during an actual FDA inspection. Correcting 483 citations is costly and can result in negative publicity.

Align with US Food and Drug Administration Laws

Whether you seek expert help inspecting your company’s quality policies or reviewing your various manufacturing practices, we are here. RAQA FDA Consultants are eager to help you become aligned with FDA regulations such as CGMP, QSM, and QSR. As such, we bring an experienced team motivated and keen to help manufacturers by sharing our expertise.

By examining your manufacturing operations’ quality policies and procedures, we can help your company achieve better compliance and provide insightful advice.

Mock FDA Inspection to Avoid a Warning Letter

Official Action Indicated (OAI) classification indicates a manufacturer is out of compliance. It’s a negative image and publicity. RAQA Regulatory Firm is here to help you as a subject matter expert (SME).

If you are a senior executive, your primary duty is to avoid receiving a warning letter (WL) from the FDA at all costs. Fixing an FDA WL will cost you time, money, and effort and may have a negative impact on your company, its products, and the morale of your people.

If you have yet to comprehend the magnitude of a Warning Letter, trust us on this. So, choose our confidential mock FDA inspection by ex-FDA investigators. Again, we don’t claim the result of our mock inspection will not result in an OAI. It’s up to you to adhere to the laws and regulations and to bring your quality to compliance.

Walkthrough During Mock FDA Inspection

During an FDA inspection under 21 CFR Part 820 (Quality System Regulation for medical devices), the manufacturing facility walkthrough—also known as the initial facility tour or floor inspection—is a critical step for the investigator. Here’s why the FDA performs walkthroughs during 21 CFR 820 inspections, and what it aims to accomplish:

Understand the Process Flow

FDA investigators want to visually map the flow of materials, components, and products through the facility, from receiving, storage, manufacturing, testing, to packaging and distribution. This helps them:

• Understand your device production process
• Identify critical control points
• See how quality is built into each stage

Verify Consistency with Procedures (SOPs)

During the walkthrough mock FDA inspection, auditors check whether the actual practices on the floor match what’s described in your standard operating procedures, quality manual, and batch records. Inconsistencies between written procedures and actual operations are common findings by the FDA.

Observe Compliance in Real-Time

The walkthrough allows investigators to:

• Observe GMP practices in real-time (cleanliness, gowning, line clearance, etc.)
• Identify data integrity risks (e.g., open logbooks, uncontrolled documents)
• Evaluate whether the equipment is calibrated, maintained, and used properly

Identify Potential Systemic Issues

They may spot signs of broader systemic failures, such as:

• Poor material segregation
• Inadequate environmental controls
• Improper labeling and traceability
• Uncontrolled nonconforming materials

Assess Employee Knowledge and Training

When conducting a mock FDA inspection, the auditor may interact with line employees or supervisors, and the investigator can determine the following:

• Whether staff are adequately trained
• If they understand and follow procedures
• Whether there’s a culture of compliance awareness

Detect Warning Signs of Poor QMS Implementation

Visual and operational red flags can suggest weak implementation of quality subsystems:

• Disorganized production areas can lead to ineffective production and inadequate process controls.
• Operators who are confused may indicate a potential issue with the adequacy of the training program.
• There is no designated quarantine area, which has led to issues with the control of nonconforming products.

Set the Tone for the Inspection

The walkthrough provides a first impression. A clean, well-organized facility with informed staff and visible control measures will establish credibility and set a cooperative tone. In contrast, confusion, clutter, or noncompliance might prompt deeper scrutiny.

In Summary, here are the FDA investigator’s goals and explanations:

• Validate process flow: Confirm how materials and products move through the facility.
• Verify actual vs. documented: Ensure real practices match written SOPs and QSR requirements.
• Observe GMP compliance: Monitor daily practices, cleanliness, labeling, storage, dress code, personnel hygiene, and other relevant aspects.
• Identify system-wide gaps: Spot problems that may indicate deeper QMS issues.
• Assess staff understanding: Evaluate if employees are trained and aware of quality roles.
• Inform inspection direction: Decide which areas/systems to focus on in detail next.

Therefore, conducting a mock FDA inspection offers production staff a chance to understand the inspection process thoroughly. Moreover, these simulations help them gain confidence in a realistic environment. Additionally, participating in drills allows them to clarify questions and concerns. Thus, this preparation ensures they are mentally and physically ready for the actual inspection. Ultimately, it increases their chances of achieving a successful outcome.