Published 31 Jan 2023
What is an FDA Inspection?
The US Food and Drug Administration (FDA) inspects facilities to ensure compliance with laws and regulations surrounding the manufacturing, labeling, and handling of food, drugs, medical devices, and cosmetics that are commercially distributed in the US. FDA inspections are conducted on both local and foreign establishments as long as the products are intended for US distribution.
This FDA Inspection Preparedness Checklist or USFDA Audit Checklist can be used to track the preparedness of a site or facility for an upcoming FDA inspection. Managers can use this as an aid to prepare the personnel, site, and documentation needed before an inspection. Use this as a guide for the following:
- Verify the preparedness of staff, facility, equipment, and all the relevant documents.
- Notify and assign tasks to the right colleagues who can work on areas or items needed for the FDA audit.
- Identify red flags to help prioritize what still needs to be done.
- Measure the inspection readiness of the facility using scoring.
- Thoroughly document internal audits through digital reports in weblink, PDF, Excel, and other formats.
In this article
- Types of Food and Drug Administration Inspections
- What is an FDA Inspection Checklist?
- Why is it Necessary to Have a Checklist for Inspection Readiness?
- What to Include in an Inspection Preparedness Checklist
- FAQs about FDA Inspections
- Prepare for FDA Inspections with a Digital Tool
- 5 Featured FDA Inspection Checklists
Types of Food and Drug Administration Inspections
The FDA prioritizes the inspection of companies that manufacture high-risk drugs and equipment. Newly registered establishments and those that have past violations are also given priority for FDA audits. Here are four types of FDA inspections that manufacturers can expect:
- Pre-approval – This type of inspection is conducted when there’s an application to market a new product.
- Routine – This is a standard inspection conducted once every two years for domestic establishments and around once every nine years for foreign facilities. If violations are found but corrective actions are immediately taken to address the issues while the FDA inspector is present, this will be noted as a positive indicator of the establishment’s commitment to stay compliant.
- “For-cause” – This inspection is intended to investigate issues or concerns that have been brought to the FDA’s attention.
- Compliance follow-up – If violations are found during an inspection, an FDA Form 483 will list them. Then, the FDA will return to reinspect to confirm if corrective actions were taken to rectify the issues previously observed.
What is an FDA Inspection Checklist?
An FDA inspection checklist, also known as an FDA audit checklist or an inspection preparedness checklist, is a valuable tool used to prepare for FDA inspections. It consists of items and areas that FDA inspectors typically look for during their visits. This tool enables you to perform and document internal audits efficiently, right in time for an FDA inspection.
Why is it Necessary to Have a Checklist for Inspection Readiness?
The primary goal of an FDA inspection is to protect consumer well-being by ensuring that only safe-to-use products are released to the market. In connection with this, new products require FDA approval before they are introduced to the US market, which is why readiness for FDA inspections should be a priority for companies.
An FDA inspection preparedness checklist is a vital component of inspection readiness for various reasons. For instance, it provides a concise overview of the things required during FDA audits. This way, you can adequately prepare for anything an inspector might ask when they visit your facility. Moreover, it also allows you to:
- Determine how compliant your facility is with FDA laws and standards, such as Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
- Anticipate potential problems during the inspection and resolve them early on
- Document protocol changes and corrective actions implemented
- Organize all necessary documents for ease of handover and review
- Comply with FDA regulations and quality standards
What to Include in an Inspection Preparedness Checklist
Now that you know the importance of having a checklist when preparing for FDA inspections, you might be wondering how to make one for your internal audits. Here are 7 things that your FDA inspection preparedness checklist should consist of:
- General Information – Begin your checklist with basic details, such as the facility to be inspected, the date of inspection, the name of the officer in charge, and the inspection location.
- Administrative – Ensure proper information dissemination among relevant staff members and a review of Standard Operating Procedures (SOP) for inspections, employee schedules, and clinical equipment.
- Regulatory – Check if all regulatory documents for FDA inspections, such as protocols, logs, disclosure forms, site SOPs, correspondences, and so forth, are complete.
- Clinical – Evaluate existing clinical practices, protocols, reports, and other necessary documentation.
- Pharmacy – Review pharmacy-related documents for completeness and accuracy, such as staff records, licenses, FDA Form 1572, participant profiles, receipts, logs, and SOPs.
- Laboratory – Look into existing laboratory records, including certifications, laboratory results, quality control data, corrective action reports, temperature logs, and so forth.
- Sign-Off – Note your comments and observations during the inspection and affix your signature as proof of FDA audit completion.
To better illustrate this, here’s a sample FDA inspection report when completed using a digital platform:
FAQs about FDA Inspections
Following the FDA Food Safety Modernization Act and the Federal Food, Drug, and Cosmetic (FD&C) Act, the frequency of FDA inspections will vary depending on the risk level of a facility. High-risk facilities will be inspected at least once every 3 years, while non-high-risk ones will be checked at least once every 5 years.
The duration of FDA inspections will depend on the following factors:
- Business size
- Type of business operations
- Number, type, and complexity of the issues found
- Review of documentation and procedures
Yes, the FDA can perform inspections without any notice in advance for for-cause inspections. Otherwise, such as for routine inspections, they will usually announce inspections around 1-14 days ahead of time.
Prepare for FDA Inspections with a Digital Tool
FDA inspections are inevitable, but you can prepare by proactively conducting regular internal audits so that compliance gaps can be found and immediately corrected. Conducting regular internal audits, however, can be time-consuming and tedious if the business is dependent on paper-based documentation.
Proof of sound GMP would require manually collecting and sorting through documents from multiple sources. Time spent on paper-based inspections and manual documentation could’ve been better spent correcting non-compliance before the actual FDA inspection happens.
SafetyCulture (formerly iAuditor), the world’s #1 mobile inspection app, can help you prepare for FDA inspections through the following actions:
- Conduct paperless internal audits using digital FDA audit checklists, templates, and forms.
- Immediately report non-compliant business areas and assign tasks for urgent issues found.
- Check the current compliance status of your facility by tracking the overall trend of measurable audit results from the app’s analytics dashboard.
- Instantly generate internal audit reports in weblink, PDF, Word, and other formats as proof of compliance.
- Conveniently share information anytime, anywhere, and review historical data on one online platform.
To save you time, we have carefully collected and converted these free downloadable digital checklists you can use on the SafetyCulture compliance audit software to get ready for the FDA inspection:
5 Featured FDA Inspection Checklists
This general GMP compliance audit checklist helps assesses the overall manufacturing practices and adherence to manufacturing protocols of manufacturing facilities. Operations managers can use this as an FDA inspection readiness checklist and help ensure that quality manufacturing standards are met. This can help with the following:
- Check the manufacturing site’s buildings and facilities, materials management, quality control systems, manufacturing, Quality Management System (QMS), personnel, etc.
- Collect data and observe compliance trends on an online dashboard to better plan for improving good manufacturing practices.
This GMP audit checklist for food manufacturers can help determine how prepared is the manufacturing site for the FDA inspection. This checklist is based on 21 CFR Part 110 and can be used by site supervisors as a guide when conducting food manufacturing audits. Use this to:
- Assess the overall condition of the food manufacturing facility, staff, equipment used, and food manufacturing processes.
- Conduct inspections on multiple sites/facilities and review the results on SafetyCulture’s online platform.
- Share audit results via web link or as an attachment.
This drug manufacturer audit checklist can be used to perform internal GMP audits for pharmaceutical manufacturing facilities. Operations managers can use this as a guide to measuring the GMP compliance of the site. Inspect the facility and assess these six focus areas:
- General quality assurance (QA) controls and procedures
- Facility controls and security
- Equipment design and placement
- Material component control
- Operational control
- Finished product control
This template was converted from the International Society for Pharmaceutical Engineering (ISPE) GMP Audit Checklist for Drug Manufacturers. All SafetyCulture templates are fully customizable to fit your business needs.
This GMP cosmetics checklist is based on the FDA’s GMP Cosmetic Guidelines. Use this to assess your manufacturing compliance with FDA guidelines. Facility managers can use this as a guide to inspecting the facilities, equipment used, staff, raw materials, lab controls, recordkeeping, and other areas.
Use the SafetyCulture mobile app to take photo evidence of non-compliance, which can serve as a reference for corrective action.