How to Prepare for an FDA Inspection

tallu said:

Hi,

Simple question: How to prepare for an FDA inspection?

1. Tips and hints are welcome.

2. And if you can keep it short - tell your stories of your companies FDA inspection.

2a. It can be the one where everything went wrong - I don't lose my night dreams after reading horror stories.
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2b. Or it can be the happy one - inspector didn't find any lacks.
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We are starting to prepare to face our FDA inspection in the end of the summer - So all posts are welcome!

ps. Our company design and manufactures Class II medical devices. Two of our devices got FDA approval.

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Hold a meeting with the resident rats and roaches - tell them to maybe take the day off.

Hi - All tips are very helpful!

I hv one question - Do we need to show production running during FDA Inspection (foreign establishment)?
Is it mandatory or good to have?

Thanks,
Sreenu

sreenu927 said:

Do we need to show production running during FDA Inspection (foreign establishment)?

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My understanding is that generally if production isn't running, FDA will schedule another day of inspection for when you say it'll be running, and will keep coming back until they can observe production activity.

sreenu927 said:

Hi - All tips are very helpful!

I hv one question - Do we need to show production running during FDA Inspection (foreign establishment)?
Is it mandatory or good to have?

Thanks,
Sreenu

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The final report will not be submitted if the any of the activities and equipment contained within the scope were not in operation during the visit.

Mikishots said:

The final report will not be submitted if the any of the activities and equipment contained within the scope were not in operation during the visit.

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You make it sound as if every single machine should be running in front of their eyes As far as I know this is quite far from being true. More likely they will look for representative equipment, unless it's a critical one. For instance, if a facility has 20 injection molding machines, I don't think that a few of them being idle during the inspection is going to be a problem. Unless one of the idle machines is very unique in some way and critical for a certain device.

Hey Guys well i think that FDA examinations are very thorough, and auditors will assume that all workers in a certain way to make sure high company's products the company generates and offers to the community.Thanks!!




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I am reading this with great interest - one item that caught my eye is this:

For instance, if a facility has 20 injection molding machines, I don't think that a few of them being idle during the inspection is going to be a problem. Unless one of the idle machines is very unique in some way and critical for a certain device.

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Does anyone have any insights as to how an investigator would go about "observing production" at a facility that produces software only?

Thanks,
Arianna

My perspective is that software production is the process of replicating the code, documentation, etc. onto distribution media, and/or other physical actions related to distribution and preparation for utilization.

Those processes involve quality steps, control steps, labeling and so forth. How do you know the copied/burned/whatever software is the right version? How do you know it wrote correctly? Was the right label applied? Are the vendors of the physical materials appropriately qualified? Are provisions in place for responsible individuals to sign off on significant actions? Are work instructions and procedures in place to standardize how the work is done?

Software design is not that much different from other kinds of engineering and development. The processes involve change control, version control, checking, conformance to work instructions and procedures, signoffs to indicate fulfillment of responsibilities, establishment of design inputs, design reviews and so forth.

My understanding is that FDA, in inspecting software related operations, focuses on the work similarities.

Well, mostly we do not replicate the code itself rather the binaries, but yes.
Labelling is a bit more tricky, because some of the labels are within the software, but mostly they are traditional labels, however for me, I would segregate labelling and packaging from the production itself, it is semantics only.
Otherwise yes, they look basically what was mentioned already.
It could be more complicated when the software is not a standalone software and a device on its own, and there is an "additional" hardware (workstation/server/etc.) that forms the device with the software.
Regards

Google "Prepare for FDA Inspection."