Author: Carrie Hetrick | Date: May 24, 2021
As a medical device manufacturer, you are likely all too aware of the looming threat of an FDA inspection of your quality systems and risk management protocols. While the FDA approval process has been known to induce sleepless nights, chronic headaches, and an overwhelming feeling of dread, knowing in advance how to prepare for an FDA inspection is key to a positive outcome.
Today, we give you pointers on how you can ensure regulatory inspection readiness in accordance with the FDA inspection guidelines for a successful meeting with your FDA inspector.
In most cases, you will receive a call in advance of an inspection, typically a week or two out—which means you have time to prepare for an FDA inspection. Start by notifying the affected personnel. Ensure they are available at the time of the inspection, advise them of their expectations and share the FDA inspection guidelines. Assign a management representative (MR), commonly referred to as an inspection coordinator, to liaise with the FDA. Designate a notetaker who will capture the dialogue, log requests and note the types of questions being asked. Book a conference room to serve as “base camp” for the duration of the inspection and have a resource on-call outside the room to gather documents as they are requested.
Your FDA inspection preparation should also include a thorough review of your company’s registration and device listings to ensure they are correct and current. Complete any housekeeping of the facility and review quality records. If issues are identified, prioritize and address them. Review any open corrective actions, MDRs, and recalls.
When the inspector arrives, he or she should remain in the lobby until the MR and the president offer a formal greeting. Have someone at the company receive the FDA Form 482 Notice of Inspection, examine the investigator’s credentials, and record his or her name.
Begin by reviewing the FDA inspection guidelines and objectives, then present the investigator with a brief overview of the company and relevant products. Take the inspector through all company policies and programs, with a focus on all positive elements. Show the inspector the finished device(s) and function to ensure a complete understanding. Then accompany the inspector on a tour of the facility, as necessary. Note, the inspector should never be left unattended.
Throughout the process, engage in a positive dialogue to establish and build rapport. Be helpful, cooperative, and open to suggestions and criticism. When answering questions, be brief and to the point. If you do not understand a question, do not answer it; either ask for more clarity or seek guidance from one of your subject matter experts. Do not volunteer any information beyond what is being asked.
Bring two copies of all pertinent documents to the room, but only provide what is being requested. The inspector should not be granted access to quality documents pertaining to internal audits, supplier audits, or management reviews. CAPA results from these documents, however, are reviewable.
Additional documents not reviewable by the inspector include:
If a Notice of Observations (Form 483) is issued, the investigator may request an exit interview to review all observations listed on the form. Ask the investigator any questions necessary to ensure you are clearly interpreting each observation. Keep in mind that the exit meeting should be used as a constructive tool to assure the FDA that the items have been or will be corrected in a timely manner and followed through to completion.
The form includes standard wording for each finding plus a write-up specific to the observations made during the inspection. Medical device companies are given the option to annotate each observation with one of the following:
The FDA expects a written response within 15 days of issuance to ensure that each observation point will be addressed. Include a corrective action plan and timeline with the following components:
Ensuring regulatory inspection readiness and navigating the process of an FDA inspection can be wrought with anxiety and stress. Do not bear the burden alone. Whether you need additional guidance on how to prepare for an FDA inspection or need help developing a quality management system that meets compliance requirements, a resource on-site during the inspection, or even some prep help through a mock inspection with our FDA compliance consulting team, Sterling can help.
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