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