How do I track the lot numbers for subcontracted work such as copings, partial frameworks, PRM’s, etc.?
You must qualify your subcontractors by having them inform you in writing that they are tracking the lot numbers and can relay that information to you should there be a recall. FDA may ask you if you have visited the facility where your subcontracted work is manufactured. This is a part of your due diligence in determining whether or not to do business with a subcontractor. If that subcontractor is in another country, then it is just as important for you to do your due diligence prior to accepting work from that subcontractor.
