Ready, Set, Prep for the Four Types of FDA Inspections

As a medical device manufacturer, Federal Drug Administration (FDA) inspections are expected, but often stressful. With expert-guided preparation and a robust FDA strategy, you can ensure you are inspection-ready now and in the future. Understanding the different types of FDA inspections, when and why they occur, and what to expect is the first step to prepare for a successful FDA inspection.

Who Does the FDA Inspect?

The FDA inspects a variety of sites, including:

• Drug manufacturers
• Medical device manufacturers
• Blood banks
• Food processing facilities
• Dairy farms
• Animal feed processors
• Compounding pharmacies relevant to your FDA inspects
• Facilities that conduct studies in people
• Laboratories that conduct studies in animals (when used to support FDA approval of medical products)

Because the FDA has limited resources to perform inspections at every site, the FDA prioritizes inspections for higher risk sites, using risk-based monitoring to determine which facilities will undergo inspection. For this reason, only a few Class I medical device sites are inspected each year, while resources are reserved for Class III and Class II sites.

There are Four Types of FDA Inspections, but They Don’t Apply to Everyone

There are four types of FDA inspections for medical device manufacturers: pre-approval inspections, routine inspections, follow-up inspections, and for cause inspections. How do these inspections differ? Which types apply to you? And how can you prepare so you pass with flying colors…or at least take corrective actions efficiently?

Premarket approval inspection (PAI)

As part of the premarket approval application (PMA) program designed to demonstrate the safety and effectiveness of Class III medical devices, the FDA will often perform a preapproval inspection. For Class II medical devices that do not require PMA, a PAI may occur following the granting of 510(k) clearance.

The decision whether to perform a PAI is determined through a risk-based assessment that includes considerations for facility, process, and product risks.

• Facility risks include factors such as CGMP issues, prior recalls, prior non-compliance or Form 483 observations (more on this later), or numerous applications filed simultaneously.
• Product risks may include considerations for the seriousness of the condition being treated, the target patient population for the device, or the novelty of the technology.
• Process risk factors include the complexity or novelty of the manufacturing process, completeness of provided data, and any risks that the manufacturing process may pose that threaten patient safety.

Medical device companies will usually receive notice five days prior to the inspection. However, if previous concerns have been identified, a company may receive less notice or none at all. Foreign manufacturers are generally notified 2-3 months in advance.

Whether you receive months of notice or none at all, QA Consulting can help you prepare and navigate through pre-approval inspections.

Routine and Follow-up Inspections

The FDA carries out routine inspections for Class II and III medical devices every two years. However, due to constraints and COVID-related changes, inspection of lower risk devices may extend longer than 2 years.

Like pre-approval inspections, you will usually receive five days of notice (2-3 months for foreign manufacturers) unless previous concerns were identified, in which case shorter or no notice may be provided. The method used during these visits is the Quality System Inspection Technique, also known as QSIT, which is discussed in more detail below.

If during a routine inspection observations are noted on an FDA Form 483, the FDA may want to perform a follow-up inspection to ensure corrective actions have taken place that adequately resolve those concerns.

For Cause Inspections

A for cause FDA inspection can occur due to:

• Significant Form 483 observations made during a routine inspection
• Significant issues reported to the FDA from consumers or employees
• Product recalls

Initiated by the FDA CDRH, ORA Headquarters, Regional or District Directive, these inspections are usually focused on the complaint or FDA Form 483 observation(s) from a prior inspection and may not follow the same format as pre-approval or routine inspections. Alternatively, inspectors may inspect areas not directly relevant to the concern. These surprise inspections are conducted as frequently as needed and you will not receive prior notification.

Watch this free webinar on how to survive an FDA inspection.

What Happens During an Inspection?

Inspections can take place on-site, virtually, or in a hybrid format that includes both on-site and virtual components. For virtual inspections, inspectors will review documentation remotely and make use of video chat platforms for interviews and walkthroughs. For an on-site inspection, inspectors will present their credentials and a Notice of Inspection, also known as FDA Form 482, upon arrival. A knowledgeable employee should accompany the inspector throughout the inspection. We also recommend recording the inspector’s name and ID number.

Before

You may want to familiarize yourself with the FDA QSIT guide. The QSIT takes a “top-down” approach. This means inspectors will first review standard operating procedures followed by quality records to ensure you are following the written procedures. Prior to arriving at a facility, inspectors will review previous inspection reports, previous FDA Form 483 observations and/or warning letters and responses to those forms/letters, your firm’s website and marketing materials, PMAs, 510(k) applications, and any consumer complaints or recalls. Prior to the inspection, the inspector may request your Quality System Manual or equivalent documentation of procedures to facilitate the inspection. If this is the first inspection, they may request additional information prior to arrival.

Key tasks prior to inspection:

• Ensure that listings and registration are current.
• Locate documents for easy retrieval.
• Communicate and coordinate with designated inspection individual and internal subject matter experts (SMEs).
• Review your quality system manual, procedures, documents, etc.
• File any medical device reports (MDRs).
• Make any required changes or address unresolved concerns.

Learn best practices for medical device document control

During

During the inspection, the inspector will examine your production process, review records, and may collect applicable samples. The inspector may also conduct interviews with key personnel. For a PMA pre approval inspection and for any first-time inspection, a comprehensive Level 2 Baseline QSIT will occur. This includes assessment of the firm’s systems, methods, and procedures to ensure that the firm’s quality management system has been properly established.

These comprehensive inspections include evaluation of all four quality subsystems:

• Corrective and preventive actions (CAPA)
• Design controls
• Management controls
• Production and process controls (P&PC)

A Level 2 Baseline QSIT will usually last for several days, roughly with one subsystem reviewed per day. You can expect this comprehensive inspection every six years. For detailed information and guidance on Level 2 inspections, refer to the FDA compliance program guidance manual “Inspection of Medical Device Manufacturers”.

During a Level 1 Abbreviated QSIT, CAPA is always reviewed, but inspection of other subsystems may vary. You can expect these abbreviated inspections to take place every two years between the Level 2 inspections that occur every six.

After

After the inspection, the inspector will discuss any significant findings with your firm’s representative and provide a written report that lists all significant observations on an FDA Form 483. You can use this form to guide corrective actions and resolve concerns.

If possible, you should respond to the observations during this final discussion and address any concerns that can be resolved quickly. In the case that you cannot respond to the observations during the final discussion, you have 15 business days to respond to the FDA Form 483.

If you disagree with the findings or have questions after the inspector has departed, you can contact the FDA’s Office of the Ombudsman.

FDA Office of the Ombudsman
10903 New Hampshire Avenue
WO 32, Room 4231
Rockville, MD 20903
Telephone: 301-796-8530
FAX: 301-847-8628
E-mail: ombuds@oc.fda.gov
Get expert insights on FDA inspection best practices.

Preparing for Routine or For Cause FDA Inspections

Inspections are to be expected, but through careful preparation you can ensure compliance, mitigate risks, and keep your medical device manufacturing workflow moving. So how can you set your facility up to be prepared for an inspection on any given day without notice?

Here are some pro-tips to ensure success in any type of FDA inspection:

• Designate an individual or, preferably, a team, that is prepared to answer questions and locate requested documentation. Designate and train this team in advance.
• Review the QSIT guide, FDA-provided guidance, and familiarize yourself and your designated team with documentation including FDA Forms 482 and 483. For PAIs, routine, and follow-up inspections, the FDA has provided thorough documentation as to what to expect. Use this information to prepare!
• Create and maintain a thorough and deliberate Quality Management System (QMS). If you need help with this, QA Consulting is prepared to help your firm generate and maintain your QMS.
• Keep meticulous records! Your records are your proof of compliance with written procedures and relevant CFR regulations.
• Designate space in advance for interviews and meetings.

QA Consulting has an established record of preparing medical device companies for all types of FDA inspections and helping to navigate for cause FDA inspections.

Leverage the expertise of QA consultants to create your medical device FDA strategy!