FDA Makes Early Stage Recall Data Public in New CORE Tool
The new tool communicates foodborne illness outbreak information as soon as FDA begins an outbreak investigation – prior to a public health advisory or recall of a certain food product being issued. The FDA Coordinated Outbreak Response and Evaluation (CORE) Network, is starting the ongoing publication of a new investigation table that will include information on all foodborne outbreaks for which the FDA has initiated an investigation. The table, which will be updated on a weekly basis, will include information about each stage of an outbreak investigation.
FSIS Posts Data on Salmonella in Poultry and Import Refusals
The import refusal data is available here. The salmonella performance testing results are available here. Aggregate results are available here.
FDA Partners with California Regulators, Industry to Cooperate on Food Safety
More details here.
FDA to Extend Comment Period on Traceability Rule
During the second public meeting to discuss the proposed rule entitled, “Requirements for Additional Traceability Records for Certain Foods,” FDA expressed their intent to extend the comment period for the information collection provisions that is set to close on November 23rd. FDA also is considering whether to provide any extension of the comment period for the proposed rule.
The Food Traceability Proposed Rule which published on September 23, 2020 included a 120-day comment period for the proposal and a 60-day comment period for the information collection provisions. After hearing concerns from several stakeholders that more time is needed to adequately review and analyze the information collection provisions with consideration to the entire proposed rule, the agency intends to formally announce an extension to the comment period for these provisions in a forthcoming notice in the Federal Register.
FSIS Inspection Directory Update
The latest directory of FSIS-inspected establishments is available here.
FSIS Updates List of Foreign Establishments Eligible to Export to the U.S.
Latest FDA Import Alerts
The latest FDA import alerts are available here and include pig ear pet treats, seafood, misbranding, pesticides and more.
Latest FDA Warning Letters:
Posted Date |
Company |
Issuing Office |
Subject |
11/20/2020 |
Vibrant Health Care, Inc. |
Center for Biologics Evaluation and Research (CBER) |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
11/19/2020 |
Pro Breath MD, LLC dba Dentist Select and OraCare |
Center for Drug Evaluation and Research | CDER |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
11/17/2020 |
WCS Trading, Inc. |
Division of West Coast Imports |
Foreign Supplier Verification Program (FSVP) |
11/17/2020 |
Ventura Foods LLC |
Division of Human and Animal Food Operations East V |
Food Labeling/Misbranded |
11/17/2020 |
Half Hill Farm Inc |
Division of Human and Animal Food Operations East V |
New Drug/Misbranded |
11/17/2020 |
World Candy Store LLC |
Division of Southwest Imports |
Foreign Supplier Verification Program (FSVP) |
11/17/2020 |
E&H Distributors LLC |
Division of Southwest Imports |
Foreign Supplier Verification Program (FSVP) |
11/17/2020 |
Quten Research Institute, LLC |
Division of Human and Animal Food Operations East II |
New Drug/Misbranded |
11/17/2020 |
Etai’s Food, Inc. |
Division of Human and Animal Food Operations West IV |
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
11/17/2020 |
Grupo Asimex de Mexico SA de CV |
Center for Drug Evaluation and Research |
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
11/17/2020 |
Family Pharmacy of Statesville, Inc. |
Division of Pharmaceutical Quality Operations II |
Compounding Pharmacy/Adulterated Drug Products |
11/17/2020 |
MXL Comercial, SA de CV |
Center for Drug Evaluation and Research | CDER |
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
Please contact Erik Lieberman at elieberman@usfoodimports.com for additional information. |