Use this FDA inspection checklist to verify the preparation of all the relevant documents to meet all legal regulations.
Use this FDA inspection template to keep track of the preparedness of a site or facility for an upcoming FDA inspection.Download template
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The FDA (US Food and Drug Administration) is a public health agency. The Food and Drug Administration determines whether regulations and laws have been followed and labelled. This inspection applies both to the American market and to products that are commercially distributed from Germany in the USA.
The FDA is concerned with the safety and effectiveness of medicines for human and veterinary use, biological products, medical devices and food. Medicines and foods are to be made more effective, safer and more affordable.
Not every approved product in Germany is automatically FDA-compliant. If you are preparing for such an inspection, it is important to proceed in a structured manner in order to be successful in the end. Below are 6 steps that are important in preparing for an FDA inspection.
Make sure your employees know and understand FDA standards. This is not only the basic requirement for good teamwork, but also essential for a positive certification of FDA standards.
During inspections and new challenges, managers and supervisors can be pushed to their limits. The right skillset is particularly important for such tasks. Not only confident handling of the norm is crucial, but also social skills such as. Empathy, stress management and the right communication in the team.
In order to prepare for an FDA inspection, it is important that the team is able to accompany the inspection appropriately. Staff should be assigned specific roles. If everyone has a responsibility, it will work more efficiently and responsibilities will be clearly defined and allocated.
The FDA does not approve foods, beverages and dietary supplements. Only the food establishments that manufacture these products must register with the FDA. After registration, an inspection may be granted for the establishment, or their products.
If a new drug does not conform to the designated monograph, it must be approved by the FDA. To obtain FDA approval, drug manufacturers must conduct appropriate clinical tests in the laboratory. Their results and collected data are then submitted to the FDA.
Companies that manufacture high-risk drugs and devices are given priority for inspection by the FDA, as are newly registered establishments and those that have committed violations in the past. Here are four examples of FDA inspections you should be aware of as a manufacturer:
1. Routine inspection
A standard inspection occurs every two years for domestic facilities and approximately every 9 years for foreign facilities. Immediate corrective action, as soon as violations are found, is assessed positively.
2. Inspection for pre-approval
This is an inspection applied before a new product is marketed.
3. inspection due to a specific problem - is used to investigate a problem about which the FDA has been informed.
4. compliance follow-up - is the second inspection of violations that have already occurred.
With a digital FDA inspection checklist, you can easily complete the inspection process, from planning to approval, via tablet or smartphone - online or offline. Use the desktop software to create your checklists for FDA approval and then analyse the data collected.
Checklists in digital form, as made possible by Lumiform's mobile app and desktop software, offer their users further advantages. With Lumiform, you will conduct standardized inspections and uncover more issues. You solve issues up to 4 times quicker by assigning corrective actions to your teammates and solving problems together. Gain real-time visibility of all issues and inspections, to prevent incidents in advance and achieve higher safety and quality standards.