FDA Releases Postmarketing Adverse Event Reporting Guidance During Pandemics
The guidance states that firms should develop continuity of operations plans (COOPs) which contemplate reporting obligations. Each firm’s pandemic COOP plan should include instructions for reporting adverse events and provide a plan for the submission of any stored reports not submitted in the regulatory timeframes. FDA does not intend to object if, because of pandemic-related high employee absenteeism, certain required adverse event reports are not submitted to the FDA within the timeframes required by statute and regulation, provided that any delayed reports are submitted within 6 months of the restoration of adverse event reporting processes to their pre-pandemic state.
Jekanowski Appointed World Agricultural Outlook Board Chairman
Dr. Mark Jekanowski has been appointed as the World Agricultural Outlook Board Chairman. Dr. Jekanowski is currently acting Board chairman and will assume his new duties on March 29. Dr. Jekanowski will be responsible for leading the development and release of the monthly World Agricultural Supply and Demand Estimates (WASDE) report. He will also serve as program chairman for USDA’s largest annual meeting, the Agricultural Outlook Forum. He replaces Dr. Seth Meyer.
FSIS Releases Foreign Audit Reports for UK, Ireland, Hungary, the Netherlands and Namibia
The latest foreign audit reports are available here.
FSIS Exercising Enforcement Discretion Over Labeling of Foodservice Products Sold at Retail
FSIS is temporarily allowing some product to move from foodservice to retail without certain required labeling elements.
FSIS Releases Updated Foreign Food Safety Equivalence List
The list is available here.
FSIS Establishment Inspectors and COVID-19
FSIS respectfully asks that establishments communicate with the in-plant FSIS inspection team to let them know if there are any known or suspected cases of COVID-19 among their establishment personnel. Guidance is available here.
FSIS Updates List of Foreign Establishments Eligible to Export to the U.S.
The most recent list provides updates related to Canada, Spain, Australia, the Netherlands, Italy and Hungary.
Latest FDA Import Alerts
The latest FDA import alerts are available here and include pesticides, lead in spices, salmonella and more.
Latest FDA Warning Letters
Posted Date |
Company |
Issuing Office |
Subject |
3/24/2020 |
Vape Orb/Slackers Brew Enterprise |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
03/24/2020 |
Vapor4Less Inc. |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
03/24/2020 |
Dragonfly eCigs |
Center for Tobacco ProductsV |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
03/24/2020 |
Fuji Food Products, Inc. |
Office of Human and Animal Food Operations East Division 1 |
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
03/24/2020 |
California IVF Fertility Center |
Office of Biological Products Operations – Division II |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
03/24/2020 |
DermaPharm A/S |
Center for Drug Evaluation and Research | CDER |
CGMP/Finished Pharmaceuticals/Adulterated |
03/24/2020 |
Hangzhou Linkeweier Daily Chemicals Co., Ltd. |
Center for Drug Evaluation and Research | CDER |
CGMP/Finished Pharmaceuticals/Adulterated |
03/24/2020 |
Bravo Packing, Inc. |
Division of Human and Animal Food Operations East II |
CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
|