In This Week’s Edition:
- FSIS Egg Substitute Sampling
- FDA Changes Address for User Fee Payments Sent by Courier
- FSIS FOIA Request Report
- FSIS Releases Audit Report for Italy
- Report on the Certification of Color Additives: 4th Quarter, Fiscal Year 2023
- FDA CORE Outbreak Investigation Status Update
- FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
- FDA Import Alerts
- FDA Warning Letters
FSIS Egg Substitute Sampling
This notice was issued to implement the FSIS Egg Products Inspection Regulations Final Rule. In that rule, FSIS stated it will assert jurisdiction of egg substitutes, freeze-dried, and agglomerated egg products on October 30, 2023. Once under FSIS jurisdiction, these products will be eligible for sampling to analyze for the presence of Salmonella and Listeria monocytogenes (Lm). The notice provides instructions to inspection program personnel for the sampling of egg substitutes, freeze-dried, and agglomerated egg products under the existing EGG_LQ_MIC01 and EGG_DY_MIC01 project codes. Egg substitutes, freeze-dried, and agglomerated egg products will be eligible for sampling under the current routine sampling programs starting on November 1, 2023.
FDA Changes Address for User Fee Payments
FDA has updated the address for BsUFA user fees delivered by courier, such as Federal Express or UPS. Beginning October 6th, to prevent any disruption of overnight packages, please send any payment arriving via courier to:
U.S. Bank
Attention: Government Lockbox 979108
3180 Rider Trail South
Earth City, MO 63045
FSIS FOIA Request Report
A new monthly FOIA Request report is available from FSIS for the month of September. Find the full report here.
FSIS Releases Audit Report for Italy
The report may be found here.
Report on the Certification of Color Additives: 4th Quarter, Fiscal Year 2023
Read the full report on the FDA certification of color additives: 4th Quarter, Fiscal Year 2023, July 1-September 30 here.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- A new outbreak of Salmonella Thompson (ref #1190) linked to a not yet identified product has been added to the table. FDA’s investigation is ongoing.
- For the outbreak of Salmonella Newport (ref #1179) the outbreak has ended, but the FDA investigation is still ongoing.
- For the outbreak of Cryptosporidium (ref #1174), the outbreak has ended, and the FDA investigation has closed.
- For the two outbreaks of Cyclospora cayetanensis (reference #1163 and #1159), both outbreaks have ended, and the FDA investigations have closed.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include coconut due to microbiological contamination, foreign processors nor in compliance with juice HACCP, and more.
FDA Warning Letters
D&A Distribution, LLC d/b/a Strictly E-cig |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Safa Goods, LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Cloud House Vape |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Rochester Smoke Shop Inc |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Be Smokeless LLC d/b/a Southwest Smokeless |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Day Light Nutrition |
New Drug/Misbranded |
Luis Javier Pena-Hernandez, M.D., FCCP |
Clinical Investigator |
Shot of Joy LLC |
Unapproved New Drugs/Misbranded |
Oceanitan, Inc. |
CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions |
Southern Tier Home Infusion, Inc. dba Pharmacy Innovations |
Compounding Pharmacy/Adulterated Drug Products |
Signature Biologics, LLC |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
Fresenius Kabi AG |
CGMP Deviations |
Infinant Health, Inc formerly Evolve Biosystems Inc. |
Unapproved New Drugs/Misbranded |