On April 28 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for April 26 that lists the status of recalls and field corrections for food, drugs, biologics and devices (here). The report covers both domestic and foreign firms.
On April 26 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration is reopening the period for comments from industry on the development of its "supply chain" pilot program under the Drug Supply Chain Security Act, it said (here). The agency is interested in “issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established” under the 2013 law (see 13121725), it said. FDA specifically requested information on using the product identifier for tracing a product, the technical capabilities of each sector of the supply chain to use the unique identifier for tracing, and "system attributes that are necessary to implement the requirements established under the DSCSA." Comments are now due April 30, 2018.
On April 25 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 24 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The National Customs Brokers & Forwarders Association of America is urging the Food and Drug Administration to allow a grace period for new Foreign Supplier Verification Program requirements that begin to take effect May 30, the NCBFAA said. “Given the complexity of the rule and widespread confusion in the trade, NCBFAA is urging FDA to allow a period where some or all of the new data elements are optional and to allow FSVP importers time to develop their supplier verification programs before enforcement begins,” the association said in an email to members. NCBFAA President Geoff Powell has been in contact with FDA's director of Enforcement and Import Operations, Doug Stearn, and has requested a meeting in early May to discuss further the need for a "soft landing" on May 30.” Stearn recently said FDA will be “mindful” of the challenges posed by the new requirements, which include submission of new data elements in ACE on the identity of the FSVP importer (see 1704040024). The May 30 compliance date applies to certain raw agricultural commodities and products from larger suppliers subject to human food preventive controls regulations (see 1602120038).
On April 20 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for April 19 that lists the status of recalls and field corrections for food, drugs, biologics and devices (here). The report covers both domestic and foreign firms.