During the week of Aug. 13-19, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination of:

The Food and Drug Administration is asking for comments on the burden of its dietary supplement labeling requirements under the Dietary Supplement and Nonprescription Drug Consumer Protection Act. The Act requires the label of a dietary supplement marketed in the U.S. to include a domestic address or domestic telephone number through which the product’s manufacturer, packer or distributor may receive a report of a serious adverse event associated with the dietary supplement. FDA expects 1,460 respondents will prepare 3.8 new labels per year for a total of 5,560 new labels, which will require an average of 0.2 hours per label, for a total of 1,112 annual burden hours. Comments are due Sept. 21.

On Aug. 17-19 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 issued a guidance entitled “Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.” The guidance contains questions and answers on FDA’s July 9, 2009, final rule requiring shell egg producers to implement measures to prevent Salmonella Enteritidis from contaminating eggs on the farm and from further growth during storage and transportation, and requiring these producers to maintain records concerning their compliance with the final rule and to register with FDA. The final rule became effective Sept. 8, 2009.

On Aug. 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Aug. 15 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 Aug. 15 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.

On Aug. 14 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 sent warning letters to two medical device manufacturers after FDA inspections that revealed non-compliance with the current good manufacturing practice requirements of the Quality System regulation. In a warning letter dated July 26, FDA warned Royal King Infant Products of Thailand that its teething rings face detention without physical examination unless and/or until it corrects violations including, among other things, verification and corrective action procedures. FDA also sent a warning letter dated Aug. 1 to Compumedics Germany for similar reasons, but did not say the company’s offending imaging diagnostic systems are subject to detention without physical examination.

Italian cheese manufacturer Ciresa Formaggi, Snc. faces detention without physical examination of its products if it doesn’t correct alleged unsanitary conditions at its plant, said the Food and Drug Administration in a warning letter. In January, FDA inspected the plant and found that Ciresa’s Taleggio cheese was stored on splintered and rough surfaces. The cheese was stored on pieces of cloth, but the edges of the cheese came into direct contact with the surface below. In its response to the investigation, Ciresa said it had placed bigger pieces of cloth underneath, but the FDA said the cloth is porous and still does not allow for adequate cleaning as required by the Current Good Manufacturing Practice (CGMP) regulation for food.