FDA Halts Food Safety Inspections, Drug Inspections in China Due to Coronavirus (COVID-19)
FDA has issued a statement highlighting the other tools it has at its disposal to protect the public from unsafe food, drug and medical device imports from China.
FSIS Lifts Ban on Brazilian Beef Imports
The ban had been put in place because of food safety and animal health concerns and has now been lifted. More information here and here.
Unilever Petitions FDA to Amend Food Additive Regs to Include Potassium Iodate
Unilever has submitted a petition proposing that the food additive regulations be amended to provide for the safe use of potassium iodate in salt added to select food categories as a source of dietary iodine. More information here.
FDA Issues Warning Letter to Jimmy John’s
FDA posted a warning letter issued to Jimmy John’s Franchise LLC for engaging in a pattern of receiving and offering for sale adulterated fresh produce, specifically clover sprouts and cucumbers. FDA also posted a warning letter to Sprouts Unlimited Wholesale Foods for supplying sprouts to Jimmy John’s which sickened 22 people in November and December 2019.
FSIS Updates List of Establishments from Canada, Thailand, Mexico and Italy to Export to the U.S.
AMS Proposes Amendments to California Olive Marketing Order
The proposed amendments would amend the Order by removing the requirement of having five producer members and five handler members in attendance to form a quorum and clarify that alternate members acting as members could satisfy the quorum requirement. AMS is posing a clarifying change to the Order’s quorum requirements by stating that alternate members acting as members to form a quorum would also be eligible to cast votes.
U.S. Codex Committee Meeting Announced on Food Contaminants; International Pesticide Meeting Cancelled Due to Coronavirus (COVID-19)
The food contaminant meeting will be held March 23, 2020 from 1:00 pm to 4:00 pm at CFSAN in College Park, MD help the U.S. formulate its positions at the 14th Session of the Codex Committee on Contaminants in Foods (CCCF) of the Codex Alimentarius Commission, in Utrecht, the Netherlands, April 20-24, 2020. The 52nd Session of the Codex Committee on Pesticide Residues (CCPR) of the Codex Alimentarius Commission, in Guangzhou, People’s Republic of China, originally planned for March 30- April 4, 2020, has been postponed indefinitely due to Coronavirus (COVID-19).
FDA Extends Comment Period on FSMA Laboratory Accreditation Rule
The U.S. Food and Drug Administration is extending the comment period for the proposed rule to establish a laboratory accreditation program for the testing of human and animal food in certain circumstances by accredited laboratories.
The proposed rule was published in the Federal Register on November 4, 2019, and comments were due by March 3, 2020. The comment period has now been extended until April 6, 2020. More information here.
Latest FDA Import Alerts
The latest FDA import alerts are available here. They include import alerts on illegal sweeteners, canned food, pet treats and more.
Latest FDA Warning Letters:
Posted Date |
Company |
Issuing Office |
Subject |
02/25/2020 |
Banjaras Inc |
Division of Southwest Imports |
Foreign Supplier Verification Program (FSVP) |
02/25/2020 |
Sassy Cow Creamery, LLC |
Division of Human and Animal Food Operations West I |
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
02/25/2020 |
Hindy Import Inc. |
Division of Southwest Imports |
Foreign Supplier Verification Program (FSVP) |
02/25/2020 |
CPAPNEA Medical Supply |
Office of Medical Device and Radiological Health Operations Division 3 West |
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
02/25/2020 |
Unetixs Vascular, Inc. |
Office of Medical Device and Radiological Health Operations (Division 1) |
CGMP/QSR/Medical Devices/Adulterated |
02/25/2020 |
KVK-Tech, Inc |
Division of Pharmaceutical Quality Operations I |
CGMP/Finished Pharmaceuticals/Adulterated |
02/25/2020 |
Market America Inc |
Office of Human and Animal Foods – East 3 |
CGMP/Dietary Supplement/Adulterated/Misbranded |
02/25/2020 |
Biomedix WAI |
Office of Medical Device and Radiological Health Operations |
CGMP/QSR/Medical Devices/Adulterated |
02/25/2020 |
JHS Svendgaard Hygiene Products Ltd |
Center for Drug Evaluation and Research | CDER |
CGMP/Finished Pharmaceuticals/Adulterated |
02/25/2020 |
Yibin Lihao Bio-technical Co., Ltd. |
Center for Drug Evaluation and Research | CDER |
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
02/25/2020 |
Essnd Global |
Center for Drug Evaluation and Research | CDER |
CGMP/Finished Pharmaceuticals/Adulterated |
02/25/2020 |
LeeSar, Inc. |
Office of Pharmaceutical Quality |
CGMP/Drug Products/Adulterated |
02/25/2020 |
Jimmy John’s Franchise, LLC |
Division of Human and Animal Food Operations East VI |
Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated |
02/25/2020 |
Sprouts Unlimited Inc |
Division of Human and Animal Food Operations West II |
Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated |
|