FDA Releases Additional Information Related to FSMA Food Traceability Rule
The information includes a flowchart on who is subject to the rule and summaries of the requirements and exemptions.
FSIS Posts Annual Foodborne Illness Outbreak Investigation Summary Reports
The reports are available here.
AMS Allows Conventional Tamarind Seed Gum as an Ingredient in Organic Products
Manufacturers may use conventional tamarind seed gum in products labeled as organic when organic tamarind seed gum is not commercially available.
FDA Voluntary Cosmetic Registration Report
The latest report is available here.
FSIS Receives Petition Requesting Policy Change to Allow for Voluntary Inspection of Imported Venison and Other Game
The petition is available here.
FDA Interstate Certified Shellfish Shipper List Update
The latest list is available here.
FNS Publishes Final Rule on Pandemic-EBT Integrity
The final rule is available here.
CDC Declares Wood Ear Mushroom Outbreak Over; FDA Concludes Investigation
Details here.
APHIS Loosens Restrictions on the Importation of South African Citrus
APHIS is removing restrictions on the ports of entry in which grapefruit, lemon, mandarin orange, sweet orange, tangelo, and Satsuma mandarin fruit from South Africa may be imported into the United States. Details 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 pesticides, misbranding, surimi, allergens, and more.
Latest FDA Warning Letters:
Posted Date |
Company |
Issuing Office |
Subject |
11/03/2020 |
Surgery Pharmacy Services Inc |
Division of Pharmaceutical Quality Operations II |
Compounding Pharmacy/Adulterated Drug Products |
11/03/2020 |
Cosmax USA, Inc. |
Division of Pharmaceutical Quality Operations II |
CGMP/Finished Pharmaceuticals/Adulterated |
11/03/2020 |
Immusist, LLC |
Division of Human and Animal Food Operations West VI |
New Drug/Misbranded |
11/03/2020 |
Fresh Express Inc – Div of Chiquita Brands |
Office of Human and Animal Food Operations East -VI |
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
11/03/2020 |
Handylee USA Corp. |
Division of Northeast Imports |
Foreign Supplier Verification Program (FSVP) |
11/03/2020 |
4E Global, S.A.P.I. de C.V. |
Center for Drug Evaluation and Research | CDER |
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
11/03/2020 |
Grupo Insoma, S.A.P.I de CV |
Center for Drug Evaluation and Research | CDER |
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
11/03/2020 |
Real Clean Distribuciones SA de CV |
Center for Drug Evaluation and Research | CDER |
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
11/03/2020 |
Asiaticon, SA de CV |
Center for Drug Evaluation and Research | CDER |
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
11/03/2020 |
Bake’N Joy Foods, Inc. |
Division of Human and Animal Food Operations East I |
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
11/03/2020 |
Physician 360, Inc. |
Center for Devices and Radiological Health |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
11/03/2020 |
LVWellness & Aesthetics |
Center for Devices and Radiological Health |
Unapproved, Adulterated, and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
11/03/2020 |
Trask and Roth Inc. dba Trask & Roth Research and Manufacturing |
Center for Devices and Radiological Health |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
11/03/2020 |
NovaBay Pharmaceuticals, Inc. |
Center for Drug Evaluation and Research | CDER |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
11/02/2020 |
Spartan Enterprises Inc. dba Watershed Wellness Center |
Center for Drug Evaluation and Research | CDER |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
Please contact Erik Lieberman at elieberman@usfoodimports.com for additional information. |