The Food and Drug Administration is inviting tobacco product importers, manufacturers, and distributors, among others, to participate in its Tobacco Product Manufacturing Facility Visits program. The program is intended to provide FDA staff with the opportunity to observe tobacco product manufacturing operations and learn about manufacturing practices and processes as they implement the tobacco provisions of the Food, Drug and Cosmetic Act. Parties interested in participating should send requests by Oct. 15.
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.
In a June 14 warning letter recently posted to its website, the Food and Drug Administration said Chinese drug manufacturer Shijiazhuang Pharma Group Zhongnuo Pharmaceuticals Co. Ltd.’s products may not be allowed entry into the U.S. until the company renews its registration. Zhongnuo had previously been notified of its lapsed registration in an FDA letter dated March 26, but the FDA said it continued to find imports of Zhongnuo’s drugs even though the company hadn’t registered in 2011 or 2012. FDA said Zhongnuo is required to submit registration information annually by electronic means for each foreign establishment it owns or operates that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug that is imported or offered for import into the U.S. Failure to register is a prohibited act under Section 301(p) of the Food, Drug and Cosmetic Act.
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.
The Food and Drug Administration (FDA) issued the August Interstate Certified Shellfish Shippers List (ICSSL). The ICSSL is published monthly for the information and use by food control officers, the seafood industry and other interested persons. The shippers listed have been certified by regulatory authorities in the U.S., Canada, Chile, Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.
During the week of Aug. 6-12, 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:
On Aug. 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 10 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 9 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 asking for comments on a draft guidance entitled “Refuse to Accept Policy for 510(k)s,” which explains the procedures and criteria FDA intends to use in determining whether a premarket notification (510(k)) submission is administratively complete and should be accepted for substantive review. FDA’s draft guidance is not in effect, but once it’s final it will be applicable to 510(k)s reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). Comments should be submitted by Sept. 27 to ensure consideration before the final version of this guidance is published.