On October 25, 2017 the Food and Drug Administration (FDA) issued a revision to Import Alert # 80-04, which was originally issued in March of 2010. Due to repetitive shipments of defective exam gloves by certain manufacturers and shippers, the FDA is approaching a strategy of detention in order to address these reoccurring violations.
When a shipment of defective examination gloves is found, it will be detained, and a recommendation for detention without physical examination will be made.
The shipper/manufacturer will then be placed on the Red List and categorized under detention Level 1, 2 or 3 accordingly:
Level 1 Detention (*)
Subsequent medical gloves will most likely be detained without physical examination (DWPE)
A manufacturer/shipper can petition FDA to be removed from the alert after five consecutive shipments where analysis of gloves shows them to be non-defective.
Level 2 Detention (**)
Firms that are on Level 1 Detention, (or which have been removed from Level 1 Detention during the preceding 24 months), that have a second defective sample found after testing and analysis will end up at Level 2 on the Red List.
The FDA’s Center for Devices and Radiologic Health (CDRH) will notify the firm in writing to address potential deficiencies in the manufacturing process and they will be provided with a copy of Good Manufacturing Process Regulations. Manufacturers/shippers will need to have at least 10 consecutive clean shipments after independent analysis before being removed from the Red List.
Level 3 Detention (***)
Firms that are on Level 2 Detention, (or which have been removed from Level 2 Detention during the preceding 24 months), that have a third defective sample found after testing and analysis will end up at Level 3 on the Red List.
A warning letter is issued by CDRH and a review/audit of the manufacturer/shipper’s export and inspectional history is conducted. Manufacturers/shippers will remain on Level 3 detention until it can be demonstrated that the medical gloves do not contain defects and that good manufacturing practices have been established. At that time, they will return to Level 1 Detention for individual shipment analysis until the manufacturer/shipper can provide evidence to be removed from detention.
The petition process takes time, so importers need to keep in mind that more shipments than what is required at each detention level may be detained and tested before FDA will stop the automatic detention of shipments.
More information on Import Alerts can be found here: https://www.fda.gov/ForIndustry/ImportProgram/ActionsEnforcement/ImportAlerts/default.htm