FDA Inspection Support

QualityHub sends a former FDA Investigator to the facility for a 3 – 4 day “inspection” that starts upon arrival at the front desk. The “investigator” remains in character throughout the inspection. The objective is to give the organization the ability to assess its team’s readiness to handle an FDA inspection and to identify areas that may pose some compliance risk. The inspection will be conducted by reviewing company policies, procedures, and work instructions, touring and observing facilities and practices, sampling and reviewing records/data, and interviewing personnel to determine compliance with regulations and company procedures. Outputs from the Client’s systems and processes will be reviewed and assessed against FDA requirements and accepted industry practices.

Where appropriate, the “investigator” will provide coaching to the audit response team and help staff understand the line of questioning, objective evidence requested, and opportunities for improvement. This “hats on/hats off” approach allows employees to get real time feedback and guidance throughout the inspection exercise.

Our former FDA investigators follow the FDA’s Compliance Policy Guides and Investigators Operations Manual in conducting their mock inspections.

Communication will be provided to the Client on an ongoing basis. The QualityHub investigator will provide feedback at daily wrap-up meetings. At the conclusion of the audit, QualityHub will conduct a final wrap-up meeting and provide verbally a list of potential 483 findings followed by a written “Mock” 483 report with executive summary and recommendations.

FDA Mock inspections can be done to simulate:

• Surveillance GMP/QMS inspections
• Bioresearch Monitoring Inspections (BiMO)
• Follow-up inspections in response to a regulatory enforcement action &
• For-Cause inspections

Our half-day FDA Inspection Training Class, “Rules of Engagement,” provides senior management and personnel expected to support an FDA inspection with an understanding of the expectations of managing the inspection in addition to post-inspection responses and follow-up with the FDA. This course is designed to help participants understand what to expect during the inspection and how to handle FDA requests, evidence, and challenges of routine or for-cause inspections. Key topics include:

• Types of records that are subject to inspection (and not),
• Roles/responsibilities during an inspection,
• Managing the Inspection in the front room and back room,
• Handling plant tours,
• Effective presentation of data/records,
• Interview techniques,
• Handling requests for photographs, affidavits, and physical samples,
• Understanding the falsification of records and the repercussions of providing false information to a federal regulator,
• Annotation of FDA-483 during close-out meetings,
• Points to consider in writing a response to an FDA-483
• …and more

QualityHub provides a former FDA investigator who will conduct a series of “interviews” with the company’s Subject Matter Experts (SMEs) who will potentially need to present data and answer questions under the stress of an inspection. Interview topics are focused on “pain points” that might include high-risk CAPAs, recent recalls, Complaints and Adverse Events, design changes for a specific product line, supplier control and monitoring, or a DHF/RMF review for a specific product.

The “investigator” role-plays, asking both typical questions and those that may be particularly difficult to answer. As responses are provided, there will be “Time-Outs” where the investigator will suggest alternative approaches or explore response strategies, or suggest improved means of interfacing with the investigator.

In some cases, the client may choose to do a 2nd round of interviews to give the SME an opportunity to re-group, develop storyboards, etc., and then start the interview again from the beginning. This provides additional practice and can help to “perfect” the delivery.

For each Interview session, you are provided with an Interview Assessment Form that provides:

• Feedback on both the SME/interviewee (strengths/weaknesses)
• Feedback on sample records reviewed and information provided, where there is an indication of potential need for improvement.

For companies that have had an FDA inspection and are preparing for a re-inspection, it is important to ensure that previous inspection observations have been remediated systemically and with adequate objective evidence to demonstrate effectiveness. QualityHub provides a Senior consultant with substantial CAPA and remediation experience to do a detailed review of the FDA Inspection CAPAs. Working with the CAPA Owner, the consultant will evaluate:

• Construct and content of the CAPA
• Investigation performed and documentation to support the investigation conclusion(s)
• Containment or corrections or rationale where these are deemed unnecessary.
• Planned and executed corrective and preventive actions.
• Objective Evidence to support all phases of the CAPA.
• Planned VOE activities and results of VOE.
• The ability of the CAPA and the CAPA owner to “tell the story”.

For each CAPA reviewed, a CAPA Evaluation Form is provided. This form is used to document the assessments of all the elements of the CAPA; deficiencies are noted along with suggestions.

After the inspection is over it is important to submit a robust response to communicate completed and planned corrections, corrective actions, and preventive actions. Responses should include timelines and available objective evidence to support the actions that have been completed. The typical response time to an FDA 483 or Warning Letter is 15 work-days and all this time should be utilized efficiently to compile a detailed and systemic response to the investigators observations. The response can impact FDA’s decision to take further action. QualityHub’s former FDA staff and Regulatory SMEs have extensive experience in writing responses and knowledge of what the FDA expects in a response. We work with your team to ensure clarity and completeness and help identify and compile the best data and objective evidence to demonstrate due diligence. QualityHub can help plan and execute remediation, including development of comprehensive Compliance Master Plans or Quality Plans that define a strategic, systemic, and well-managed approach to executing remediation activities. We have subject matter experts and interim professionals who can provide hands-on assistance in planning and completing corrective actions or back-fill routine jobs while the management team is diverting their time to overseeing remediation efforts.