The Food and Drug Administration issued its weekly Enforcement Report for Oct. 24 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 Oct. 24 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Oct. 23 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The Food and Drug Administration on Oct. 24 posted a new draft guidance document outlining verification requirements for pharmaceutical manufacturers, wholesale distributors, dispensers and repackagers under the Drug Supply Chain Security Act. The draft guidance includes recommendations for verification systems required under the law for the determination, quarantine, and investigation of suspect and illegitimate products. It also addresses how “trading partners” under DSCSA should submit cleared product notifications after a product is found after investigation not to be legitimate, and addresses the statutory requirements for verification, FDA said. Under DSCSA, manufacturers and repackagers are also required to respond to requests for verification from other trading partners, and verify certain information prior to further distributing returned product.

On Oct. 22 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Oct. 19 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 seeks comments on the burden on importers from its information collections under the Foreign Supplier Verification Program regulations, it said. The agency is set to request an extension from the Office of Management and Budget for existing information collection requirements under FSVP. The approval would cover reporting and record-keeping requirements. Comments on the requirements and FDA’s estimate of their burden on importers are due Dec. 21.

The Food and Drug Administration issued a new draft guidance document intended to help farms comply with its produce safety regulations. “The draft guidance provides a broad range of recommendations on how to meet the requirements for most subparts of the rule,” the agency said. “It also outlines how to determine whether produce or farms may be eligible for exemptions from certain requirements, or from the rule in its entirety.” FDA intends to hold a series of public meetings to discuss the draft guidance before its finalized, and will announce the meetings in separate Federal Register notices, it said. Comments on the draft guidance are due April 22, 2019.

The Food and Drug Administration released a draft update to an existing guide on minimizing food safety hazards from fresh cut produce. The update includes new information related to recently amended current good manufacturing practice requirements and new preventive controls regulations for human food, FDA said. It applies to fresh fruits or vegetables that have been physically altered from their whole state after being harvested from the field (e.g., by chopping, dicing, peeling, ricing, shredding, slicing, spiralizing, or tearing) without additional processing (such as blanching or cooking). Once finalized, it will supersede guidance issued in 2008, FDA said. Comments are due April 22, 2019.

The Food and Drug Administration released the new import filer evaluation procedures and some early feedback on the procedures in an Oct. 12 letter to the National Customs Brokers & Forwarders Association of America. "The process is now final and is the expected method of conducting filer evaluations by all our field offices," said John Verbeten, director of the FDA's Division of Import Operations. "Of course, with any new program, especially one national in scope, there will be an adjustment period and both FDA and the filing community should be prepared for hiccups; continuing our good communication will be key in getting the program running smoothly." The agency also provided a flow chart of how the evaluations work. The FDA said in September it began the new processes and it planned to provide details to the NCBFAA (see 1809250041).