Update on FDA Inspections of Dental Laboratories By Mary Borg
Maybe it’s just that certain dental laboratories that are registered with FDA have come up on what FDA refers to as their “inventory”, but a number of dental labs have been audited in the past two months. Georgia is definitely on the radar so if you’re located in Georgia and are registered with FDA or are involved in activities that require you to register with FDA but you haven’t, then be prepared.
Over the past eight years, articles in JDT Unbound’s Risky Business section have provided you information on the subject of FDA registration, FDA inspections, and qualifying your suppliers and subcontractors. It’s time for you to go back and read those articles so you can ensure that you understand what’s required by FDA in these regards. They are archived in JDT Unbound and appeared in the following months/years:
August 2008: Qualify Your Vendors/Suppliers and/or Subcontractors
January 2010: Know Your Outsourcer!
February 2011: FDA Registration – Fact or Fiction?
September 2012: FDA Revises Medical Device Establishment Registration Fees and Requirements
What seems to be occurring and is definitely a concern is that not all foreign manufacturers are registered correctly. It appears that some will list every FDA Product Code if it has any word in it that refers to a dental material or term. If a foreign dental laboratory actually manufactures porcelain powder, then they would have to have a 510(k) clearance on the material, however, if they are using an FDA cleared porcelain manufactured by Dentsply or Noritake, for instance, then they would not list the porcelain powder on their registration but rather the PFM product code. These product codes usually begin with an “N”.
Why is that important for the U.S. dental laboratory that is importing? Because the U.S. dental laboratory must register with FDA as an importer or repackager/relabeler if they are receiving shipments direct from the foreign manufacturer and list the items being imported which must match the items that the foreign dental lab lists on its registration. The February 2011 article referenced above goes into detail on the product codes and types of listings. Also, the foreign dental lab, as explained in the September 2012 article regarding the changes in FDA registration requirements, must disclose the names of its U.S. customers to FDA. This is another way for FDA to locate the U.S. importers and ensure that they are registered with FDA.
If the foreign manufacturer is registered incorrectly, then that problem can flow down to its U.S. customers who may also be registered incorrectly. In turn, FDA will think the U.S. dental laboratory is doing one thing, when in actuality it is not. The onsite audit by FDA can start out in the wrong direction and create undue stress on the U.S. customer. Do your due diligence on this issue so your inspection by FDA will address the correct activities and products that you’re importing.
Update on FDA Inspections of Dental Laboratories By Mary Borg
Maybe it’s just that certain dental laboratories that are registered with FDA have come up on what FDA refers to as their “inventory”, but a number of dental labs have been audited in the past two months. Georgia is definitely on the radar so if you’re located in Georgia and are registered with FDA or are involved in activities that require you to register with FDA but you haven’t, then be prepared.
Over the past eight years, articles in JDT Unbound’s Risky Business section have provided you information on the subject of FDA registration, FDA inspections, and qualifying your suppliers and subcontractors. It’s time for you to go back and read those articles so you can ensure that you understand what’s required by FDA in these regards. They are archived in JDT Unbound and appeared in the following months/years:
August 2008: Qualify Your Vendors/Suppliers and/or Subcontractors
January 2010: Know Your Outsourcer!
February 2011: FDA Registration – Fact or Fiction?
September 2012: FDA Revises Medical Device Establishment Registration Fees and Requirements
What seems to be occurring and is definitely a concern is that not all foreign manufacturers are registered correctly. It appears that some will list every FDA Product Code if it has any word in it that refers to a dental material or term. If a foreign dental laboratory actually manufactures porcelain powder, then they would have to have a 510(k) clearance on the material, however, if they are using an FDA cleared porcelain manufactured by Dentsply or Noritake, for instance, then they would not list the porcelain powder on their registration but rather the PFM product code. These product codes usually begin with an “N”.
Why is that important for the U.S. dental laboratory that is importing? Because the U.S. dental laboratory must register with FDA as an importer or repackager/relabeler if they are receiving shipments direct from the foreign manufacturer and list the items being imported which must match the items that the foreign dental lab lists on its registration. The February 2011 article referenced above goes into detail on the product codes and types of listings. Also, the foreign dental lab, as explained in the September 2012 article regarding the changes in FDA registration requirements, must disclose the names of its U.S. customers to FDA. This is another way for FDA to locate the U.S. importers and ensure that they are registered with FDA.
If the foreign manufacturer is registered incorrectly, then that problem can flow down to its U.S. customers who may also be registered incorrectly. In turn, FDA will think the U.S. dental laboratory is doing one thing, when in actuality it is not. The onsite audit by FDA can start out in the wrong direction and create undue stress on the U.S. customer. Do your due diligence on this issue so your inspection by FDA will address the correct activities and products that you’re importing.
