The Food and Drug Administration warned an Indian food exporter that it may be put on import alert because of violations of emergency permit control and acidified food regulations (here). In a letter dated Nov. 12, the agency told KIZ Foods Limited that an FDA investigator visited the company’s Bhavnagar, India facility and found a multitude of violations. Unless the violations are corrected, FDA may place food produced at the facility on detention without physical examination, it said.
The Food and Drug Administration on Nov. 19 announced it is postponing the date it will require unique device identifiers (UDIs) on certain single-use implantable medical devices that must be sterilized before use (here). Under a final rule issued in September 2013 (see 13092020), implantable devices don’t necessarily have to be directly marked with a UDI, but the UDI must be available at the time they are used, said FDA. This can be difficult for implantable devices that must be sterilized, because they have to be separated from their labeling before the additional step. Although Class I implantable devices had to comply by Sept. 24, 2014, and compliance was required for all other implantable devices by Sept. 24, 2015, FDA is now giving companies until Sept. 24, 2016 to meet UDI labeling requirements for certain devices listed in the agency’s notice. However, the effective date of the requirement to submit information to the Global Unique Device Identification Database (GUDID) is unchanged, said FDA.
On Nov. 18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Nov. 17 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 posted the latest version of its guidance on registration of domestic and foreign food facilities. In the sixth edition of its “Questions and Answers Regarding Food Facility Registration” (here), FDA provided information on how it will treat farms that only pack or hold food produced by another farm under different ownership, in light of an ongoing rulemaking that would exempt such farms from registration requirements. FDA said it “does not intend to prioritizing the registration requirement” under these circumstances.
On Nov. 14 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Nov. 13 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 Nov. 12 that lists the status of recalls and field corrections for food, drugs, biologics, and devices (here). The report covers both domestic and foreign firms.
The Food and Drug Administration issued the Interstate Certified Shellfish Shippers List (ICSSL) for November (here). 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, South Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.
On Nov. 10 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: