Defective condoms present a potential hazard to health.
Therefore, continuous monitoring of these devices is needed. Districts should collect representative samples from all other shipments of imported latex or synthetic material condoms that are not on detention without physical examination. DIOP has direct reference authority for detention without physical examination of condoms. When a district encounters a shipment of condoms which is found violative for defects by FDA analysis, the shipment should be detained and a recommendation for detention without physical examination should be forwarded to DIOP, HFC-170. The importer may obtain admission of subsequently detained shipments of condoms by presenting evidence that the individual shipments are not adulterated, such as sample analyses performed by an independent testing laboratory, following the sampling plan and test method contained in FDA guidance.