NDAs and FDA Inspections
Happy New Year everyone!
Hoping the community can help me with a challenge I have been running into. Below is my scenario:
Company A licenses franchised restaurant chains in the US.
The restaurants have products delivered to them from a third party manufacturer.
These manufacturers are also franchised owned, by the same franchisees who own the restaurants.
Company A, which is also corporate, is responsible for all supplier approval processes for the restaurants and the manufacturers.
The restaurants and the manufacturers are responsible for verifying all incoming goods are from approved suppliers.
During our FSMA inspections at the manufacturers, we have been running into some challenges because corporate keeps the supplier records while the manufacturers only keep their verification records. Due to NDA's, my team is being told that due to the confidentiality agreement that is in place between Company A (Corporate) and the suppliers, we are unable to show the FDA any third party audit reports or any completed questions that we have on file due to this agreement.
Our FDA inspector pushed back during their last visit, stating the NDA does not stand when it comes to the FDA requesting documents and by not providing them to the FDA we are refusing the government.
I don't understand why we are unable to show the FDA the full audit report along with any other supplier records that were requested during the initial approval process and the ongoing approval process. The FDA has no buy in with our company and there shouldn't be any issues. All records that we have on file, we are able to stamp/watermark as confidential to ensure nothing is posted publicly.
Any guidance is much appreciated!
Thank you!
Weebus90
This seems quite simple. You don't have to show the FDA anything. And they don't have to let you do business....lol.
For me, the FDA is the one entity that can walk up to my door, slap a sticker on it, and we are shut down until they say we're not. I'd give them what they ask for if it were me.....
This would not work with 2nd or 3rd party auditor as well.
As a former SQF Auditor I was told more times than I can remember that NDA's prevented a compamy from sharimg the info that I needed to review - and I had companies actually refuse and thus the audits were stopped or they C'd and/or haf to do over again amd then they always seemed to be able to provide the information.
When I worked for smaller businesses I used to make a point of reading through all NDAs before we signed them, and advising that we should refuse to sign anything that aims to prevent us sharing information with regulatory bodies and/or certification bodies and their auditors. This was quite a common occurrence as the wording seemed to generally be very broad.
99% of the time, the customer wanting the NDA signed would come back and advise that they hadn't thought about that, and were happy to agree an amended NDA to include specific provision that data could be shared in these circumstances.
Occasionally we'd get a customer who'd insist that they didn't want anything shared with anyone (usually they were a small business who was a bit delusional about how "amazing" their recipe was), but again they'd usually change their mind when we explained that if we can't share anything then we can't maintain the BRC certification they insist on us having.
Obviously in a larger corporate structure these often go through some central legal/commercial team, so it might be worth flagging this up to them and asking them to check the actual wording, and if needed to then also clarify with the other parties to the NDAs that these can't override your obligations to share data with certain other parties such as the FDA. It might be that the message has got a bit muddled, or that no one actually considered this but once aware of it they can appreciate it and get it fixed.
I would provide the FDA with the records they are asking for, otherwise, they can shut the company down.
Thank you everyone for your help and guidance, it is much appreciated!
Thank you everyone for your help and guidance, it is much appreciated!
We'd (I'd) love to know what happened!!