Food and Drug Administration sources have informed Broker Power that PREDICT1 is currently deployed in 11 Districts, and the FDA expects to deploy PREDICT to its Detroit District next.
On May 19, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration announces that Nielsen-Massey Vanillas, Inc. of Waukegan, Illinois is voluntarily recalling lot no. 11123 of its Madagascar Bourbon Pure Vanilla Bean Paste because it has the potential to be contaminated with Listeria monocytogenes. This recall extends nationally to all states of the U.S. and Canada, and extends to all levels of distribution.
On May 18, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
On May 17, 2011, the Food and Drug Administration updated Import Alert #99-33 on detention without physical examination of certain milk, milk products, fruit, vegetables, and baby formula from Japan due to radionuclide contamination. The update (i) removes the prefectures of Chiba, Gunma, and Saitama from the list of prefectures subject to detention without physical examination and (ii) adds bamboo shoots and ostrich fern from the Fukushima prefecture to the list of products restricted by the Government of Japan. Updated Import Alert available here. Updated FDA list of frequently asked questions (FAQ) available here.
On May 17, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration is announcing the availability of an updated Compliance Policy Guide Sec. 335.700, "Surgeons’ Gloves and Patient Examination Gloves; Defects - Criteria for Direct Reference Seizure." The CPG, originally issued in 1991, provides guidance to FDA staff on the submission of seizure recommendations for medical gloves that exceed the defect levels in FDA regulations. The CPG has been revised to remove an appendix that became obsolete when the regulations were amended, and to make other minor changes for clarity and consistency with the amended regulation.
On May 16, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration is warning consumers not to use products marketed as dietary supplements that also claim to be antimicrobial (antibiotic, antifungal or antiviral) drugs, including Amoxilina, Pentreximil, and Pentrexyl Forte Natural. These illegal products are falsely promoted with claims to treat illnesses such as upper respiratory infections, sinusitis, pneumonia, bronchitis and the common cold. FDA has determined that many of these products mimic the labeling of drugs available in Mexico, and that they are marketed specifically to the Hispanic community.
The Environmental Protection Agency has announced that it is accepting comments, by June 1, 2011, on its draft guidance on the certification of reported values for ENERGY STAR requirements. This guidance is intended to address the need for manufacturers to report consistent information on product performance, and is based on practices already being implemented by some certification bodies.