Hello Anon,
These are good questions and going through a foreign establishment inspection by FDA the first time can be a little scary.
- For flights and accommodations these are all covered by the US FDA. In fact, usually on a foreign establishment inspection, the investigator is doing 3 or 4 facilities in one trip, so usually there is only 1 flight and then staying at the different hotels depending on proximity of the companies. For hosting, this would be standard hosting of an audit where accommodations for lunch should be made, i.e. bring in food or allow time for visit to the company canteen - do not take them out during lunch, this is frowned upon and wastes time. You can "invite" an inspector to dinner or offer places they can eat, but the dinner expense would be made by the investigator - you can not buy them dinner ;). For lunch, if it free or discounted for the employees, it would be the same for the investigator. Resources and time would be like any other audit as there will many people consumed with the inspection - definitely make it a priority and have individuals available to provide documents, records, and time for interviews. If you need translators, this would be at the company cost. If you need to bring in external resources, i.e. consultants, this would at the company cost.
- It really depends on how the establishment registration have been set up in the US FDA FURLS database. If your facility who manufacturers a 510(k) Exempt and/or GMP Exempt device is registered as a Manufacturer, but also the facility is registered as a Contract Manufacturer for another company, the investigator may look at both at the same time or only one part. In fact, when you receive the questionnaire for local airport and accommodations, in the communication it would be helpful to clarify or indicate which "operations" would be or are going to be reviewed. Also when the investigator is first at the facility during the opening meeting, this is really important to clarify and confirm with the investigator. It can be quite annoying for them getting through most of the first day getting into complaints, corrective actions, or manufacturing and realising the company manufactures all these other products. It is better to be up front with everything, because it can lead to a more challenging inspection if there is a perception of hiding things. Depending on the proximity of the combination product legal Manufacturer this site may already be on the FDA investigator's list of companies to visit - but during routine inspections the time would be allotted to conduct the inspection at your facility.
There are information contained in the Program Compliance Guide for conducting inspections https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals/compliance-program-manual. If your organisation has not been through an inspection before, it might be helpful to get some external resource to help prepare understanding how to answer questions, timeliness of document requests, what type of information is provided, who should be interviewed, etc., it does take some experience going through inspections to learn the process as not something which can be readily taken from a written manual. Luckily with the maturity and openness of US FDA, these inspections are definitely more structured and know what to expect versus other regulatory agency audits or inspections.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 10-Apr-2024 09:18
From: Anonymous Member
Subject: FDA site inspection of Foreign Establishment
This message was posted by a user wishing to remain anonymous
Hello!
I have a couple of questions on FDA Inspections.
1. Does anyone know what the costs and/or fees are for hosting a site FDA inspection at a foreign establishment, excluding resources, time and food? Do the host have to pay for flights and accommodation or is it like other Governments agencies where they cover their own costs?
2.A manufacturer who only manufactures an exempt device under their own name also contract manufactures a combination device for others and have been notified of an FDA site inspection at the foreign establishment. How likely are the FDA to audit the legal manufacturer of the combination device?
If there are any guidance / rules you could point me to on the above that would be great.
Thanks in advance for your help.