On Oct. 3 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 Oct. 3 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. 2 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The Food and Drug Administration is allowing more time for comments on a recently issued draft guidance document on agency decisions not to issue export certificates for medical devices. FDA can refuse to issue an export certificate in cases in which there is an ongoing injunction proceeding, seizure action or class I or II recall associated with a device, or the device establishment is not in compliance with FDA quality system regulations, it said. Exporters denied a certificate can request an FDA review of additional information. Facilities that have received an FDA inspectional observations form can still obtain export certificates by submitting a plan of correction to the relevant FDA office, the draft guidance said. An extra 30 days are available to submit comments, which are now due Nov. 15.

On Oct. 1 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. 2 issued a guidance document on the labeling of injectable medical products for human use. The guidance sets out appropriate package type terms and discard statements for injectable drugs, biologics and combination products packaged in multiple-dose, single-dose, and single-patient-use containers, respectively. “FDA believes that consistent use of correct package type terms and discard statements for injectable medical products for human use will promote their proper use and provide a foundation for educational efforts to reduce the transmission of blood borne pathogens,” it said.

The Food and Drug Administration recently issued a draft guidance document outlining situations in which it will publicize the names of downstream retail consignees that may have received food subject to human and animal food recalls. FDA has the authority to disclose confidential commercial information if necessary to put a recall into force, it said. The agency intends to publicize retail consignee lists for food recalls when “(1) the food is not easily identified as being subject to a recall from its retail packaging (or lack thereof); and (2) the food is likely to be available for consumption (i.e., given its shelf-life or perishability, it may still be in a consumer’s possession),” it said in the document. Examples of these types of food include fruit and vegetables, deli cheese and nuts sold in bulk, FDA said.

On Sept. 28 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 amending its food additive regulations to permit the use in feed and drinking water of animals of 25-hydroxyvitamin D3 as a source of vitamin D3 activity for layer and breeder chickens and turkeys. DSM Nutritional Products filed the underlying petition. The change takes effect Oct. 2.

On Sept. 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: