The Food and Drug Administration may do a reinspection of Korean seafood processor Shinhan F&B Co.’s facility and assess associated fees, so the company “should consider providing [its] U.S Agent with a copy” of the associated warning letter, it said. The warning letter appears to be the first posted to the FDA website that contains language on U.S. agent liability for reinspection fees. FDA said the facility’s violations of the Seafood Hazard Analysis and Critical Control Point regulation constitute “noncompliance materially related to a food safety requirement of the Act,” and is therefore liable for the fees. FDA also threatened to place the facility’s products on detention without physical examination.
On Nov. 26 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 final rule to establish Jan. 1, 2016, as the uniform compliance date for food labeling regulations that are issued between Jan. 1, 2013, and Dec. 31, 2014. FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. (FDA previously established Jan. 1, 2014, as the uniform compliance date for food labeling regulations issued between Jan. 1, 2011, and Dec. 31, 2012.)
The Food and Drug Administration said it intends to take enforcement action against unapproved injectable drug products containing sodium nitrite or sodium thiosulfate labeled for the treatment of cyanide poisoning, as well as against persons who manufacture or cause the manufacture or distribution of such products in interstate commerce. The antidotes carry serious risks, and unapproved drug products may lack warnings required in the labeling of approved cyanide antidotes, FDA said.
The Food and Drug Administration submitted its proposed rule on “Accreditation of Third Parties to Conduct Food Safety Audits and for Other Related Purposes” for approval by the Office of Management and Budget Nov. 24. The rule would set out regulations on FDA’s use of accreditation bodies to approve third-party auditors. The third-party auditors would conduct certifications foreign establishments for use in FDA’s coming Voluntary Qualified Importer Program (VQIP), pursuant to the Food Safety Modernization Act.
On Nov. 21 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. 21 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On Nov. 20 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 warned Chinese and Japanese device manufacturers that their products do not conform to current good manufacturing practice (CGMP) requirements of the Quality System regulation, in two warning letters dated Nov. 13. Premarket approval applications for related devices, and Requests for Certificates to Foreign Governments, will not be approved until Chinese company A&D Electronics (Shenzhen) (here) and Japanese company Osachi (here) correct the violations, FDA said. In its warning letter to Osachi, FDA also said the company’s devices are misbranded because it has no written Medical Device Reporting procedures.
The Food and Drug Administration said in two warning letters that it may place devices manufactured by United Kingdom-based Integra Neurosciences (here) and Denmark-based Tonica Elektronik (here) on import alert after inspections revealed deviations from current good manufacturing requirements at both companies’ facilities. Integra also offered for sale a non-FDA approved device in a catalog distributed in the U.S., FDA said in its warning letter to the company. Both facilities will be subject to reinspection to ensure compliance, FDA said.