FDA has issued its weekly Enforcement Report for Dec. 9, listing the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.
On Dec. 8 FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 7 FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 4 the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
FDA will allow food facilities to temporarily register or renew their registrations without a DUNS number ahead of the agency’s Dec. 31 deadline for food facility registration, it said in a recently issued guidance document (see 2012040012). Beginning with the 2020 registration period that began Oct. 1, food facilities are required to provide a unique facility identifier, which may be a DUNS number. But to “address stakeholder concerns with obtaining a DUNS number in a timely manner,” FDA will allow registrants to enter “pending” in the UFI field of their registration. The registrant will then have 90 days to update their registration with a DUNS number, FDA said. Failure to update within 90 days will result in cancellation of the registration for failure to renew, the agency said.
On Dec. 3 FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
FDA is revoking emergency use authorizations for certain protective barrier enclosures, as well as certain infusion pumps and infusion pump accessories, the agency said in a notice released Dec. 3.The revocations took effect for protective barrier enclosure EUA as of Aug. 20, and the revocation of the infusion pump EUA took effect Sept. 21, FDA said.
On Dec. 2 FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
FDA has issued its weekly Enforcement Report for Dec. 2, listing the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.
On Dec. 1 the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of: