Hello Dear Audit Division Community! 😊

Thanks in advance for your help ~ I am curious if anyone knows of an Industry guidance, white paper or document regarding hosting food/dietary supplements' regulatory inspections IF YOU ARE NOT A MANUFACTURER, BUT A BRAND OWNER.

My understanding is that if you are a brand owner that subcontracts with co-manufacturer to make your product, is very unlikely the FDA will show at your door, but brand owners do and have received warning letters in the past, with a subcontracted mfg product (i.e. Warning Letter 539361 - 03/13/2018 & Warning Letter 579475 - 08/23/2019)

There are some white papers and guidance docs on hosting FDA audits if you are a manufacturer, but my question is: what if you are just the brand owner? What should you have as min in your procedure?

Thanks Again!

L. Tatiana.