Common Questions About Preparing for FDA Inspections and Dealing with Inspectors Answered
FDA inspections can be events that generate an enormous amount of tension among employees and management. Preparing for inspections is an ongoing basis process. You have to make sure that your company is in compliance with existing regulations and all personnel are aware of these and given adequate training to interact with the FDA inspector. But there are still questions and misconceptions about certain elements of the inspection process that can trip up even the most prepared organization.
On this webpage there are some of the most common questions and expert's answers regarding FDA inspections.
Q1. Does the inspector look at a company's website for specific claims about a product either before or during the inspection?
They will look at the website before the inspection. If an FDA inspector knows that she or he will be inspecting your firm, one of their preparations will be looking at the website and they might also ask for your quality manual. When they do an unannounced inspection, they will have looked at the company website beforehand.Q2. Are Pre-Approval Inspections (PAIs) for a company's first NDA pre-announced?
Usually, they are not. Companies submitting their first NDA don't as yet have an established relationship with the FDA, so the PAI is not pre-announced.Q3. Does the FDA request documents throughout the day of the visit or do they present you with a list?
They will do both. For example, the inspector could ask for a summary of product complaints. Alternatively, they could also give you a list of specific 20 complaints that they'd like to see. On seeing these, the inspector could say, "I see that this particular complaint references a corrective action investigation - could you bring the details?" So, they could ask for a list or they could ask for various documents throughout the day.Q4. What period of time is considered acceptable in turning around with the requested documents?
You should be able to give the documents within a reasonable amount of. The longer it takes you the more negative is the impression created.Q5. What should you do if the requested documents are stored offsite?
Storing documents can be a problem for companies as these take up space. Documents are likely to be scanned and stored on systems and the originals stored offsite. In such cases, it could take time to retrieve the originals. The requirement by the FDA for documents during inspection is that documents be reasonably available. So if a requested document has been stored offsite, you have to tell the inspector that the requested document is in an offsite storage facility and will be made available to them as soon as possible for them to inspectQ6. Are all items on the Form 483 equally important?
Yes, you need to respond to each of them when you respond to the Form 483. For example, don't omit observation number 5 because it's merely a documentation error while the other eight items are systems errors. All the items on the 483 are equally important. If an error were more significant or pressing, the FDA would note it in a warning letter.Q7. Does a reason have to be specified for a disputed or undetermined date for corrective action when annotating an item on the FDA 483?
You do not have to specify the reason. You have to make it clear to the inspector that it is undetermined. You have to say that you intend to carry out the corrective action for this item but you are not sure about the date by which it will be completed. This will make it clear to the inspector that the item in question is not disputed.Q8. If the Establishment Inspection Report (EIR) is not received within 120 days, is there a typical timeframe for the unexpected visit by the FDA inspector?
No - there isn't a typical timeframe in such a situation. If you do not receive the EIR within 120 days, it doesn't necessarily mean a warning letter will follow - it's just something that you need to follow up on. A good rule of thumb is, once you've responded to the Form 483, and the date to which you'd committed to completing your corrective actions has expired, then you can receive the FDA inspector's unexpected visit shortly thereafter. The FDA will not come the day after your last corrective action was expected to be done. If you've given yourself three months to complete your 43 items and 120 days have passed, then a month after 120 days is a reasonable time for you to receive the unexpected visit.Q9. When the affidavit is read back to you do you have to acknowledge it?
No - don't let them begin to read the affidavit to you. You can leave the room or do something a little less obvious so that you are not able to acknowledge the affidavit.Q10. What would be the purpose of the affidavit if the firm were not to sign or acknowledge it?
The purpose of the affidavit is to get the company to admit to a completely unacceptable practice or situation. This is the sole purpose of an affidavit. This is why you should not sign or acknowledge it. You do not want a legal document to exist in which you acknowledge that a non-compliant practice or situation occurred.These questions are just a small part of the various issues that may crop up before, during or after an FDA inspection. To gain a better understanding of FDA inspections and how you can manage them better, attend any of the following ComplianceOnline seminars and webinars:
FDA Inspections: Understanding the Core Elements
The FDA Inspection: Best Practices for Preparation, Management, and Follow-Up
