On July 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
FDA on July 2 created new Import Alert 66-78 for drugs that appear to be adulterated based on analytic test results. The import alert, which does not yet list any products for detention without physical examination (DWPE), covers “drugs, including finished dosage drug products and active pharmaceutical ingredients, considered at risk for adulteration that pose a health risk due to contamination, substandard quality, or ingredient substitution.” Reasons for listing include instances in which testing has revealed harmful impurities; violations of current good manufacturing practices; substandard strength, quality or purity; drugs not recognized in an official compendium; mixing or packing to reduce quality or strength; and drugs that have been entirely substituted. “To secure release of an individual shipment subject to DWPE under this Import Alert, the importer and/or another responsible party to the shipment should provide evidence that the shipment does not contain drugs that appear to be adulterated,” FDA said.
The FDA issued its weekly Enforcement Report for July 1 that lists the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.
On June 30 the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
FDA created a new import alert on June 30 for filtering facepiece respirators that are not authorized by the agency or otherwise don’t meet National Institute for Occupational Safety and Health (NIOSH) standards. Import Alert 89-18 authorizes FDA import divisions to “detain, without physical examination, shipments of FFRs identified on the Red List of this Alert,” it said. No FFRs are yet listed as of press time. “If an FFR is detained, the importer may submit a reconditioning application to FDA under 21 CFR 1.95. The importer will need to submit the Form FDA-766 directly to the Import Division compliance officer handling the entry. Additional requirements for release may be requested depending on the situation,” the import alert said. “To be reconditioned as a face mask, among other things, the article would need to be labeled accurately to describe the product as a face mask, and to not claim to be intended for use as a surgical mask or as a FFR,” it said.
On June 29 the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 26 the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
FDA is again calling on importers and others in the supply chain to “take action to break the cycle of recurring outbreaks of Salmonella infections associated with imported papayas.” In a letter dated June 25, the agency requested that “all segments of the papaya industry” identify and implement best practices to prevent contamination, including some recently published by the Mexican government and U.S. industry groups. The letter follows up on an FDA August 2019 letter to industry on outbreaks related to imported papayas (see 1908280014). “Our hope is that 2020 will be the year when our collective efforts to prevent outbreaks are successful, and American consumers can enjoy papayas, confident in their safety,” FDA said.
On June 25 the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 24 the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of: