On Nov. 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
During the week of Nov. 19-25, 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 and/or surveillance of:
The Food and Drug Administration warned Korean device manufacturer Mi Gwang Contact Lens Co. that its premarket approval applications and federal contracts may be refused for violations of current good manufacturing practice (CGMP) requirements. The warning letter also detailed violations of the Medical Device Reporting regulation. FDA told the company to respond to the allegations with corrective actions within 15 days of receipt of the Nov. 13 letter.
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.