U.S. Food and Drug Administration (FDA) Archives - Page 34 of 42

On February 1, 2013 Many Food Facilities Face Suspension

The U.S. Food and Drug Administration (FDA) extended the deadline for the biennial registration renewal for food facilities until January 31, 2013. Your time is almost up to re-register! If your not re-registered, enforcement will begin on February 1, 2013. FDA will cancel your Bioterrorism Act registration and your importations will be significantly delayed. Your facility will NOT be able to import, distribute or sell food products in the U.S.

Here’s what you need to know about FDA’s new FSMA requirement on Bioterrorism Act registrations. Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food, alcoholic beverages, and/or dietary supplements for consumption in the U.S. are required to register the facility with the FDA.

The Food Safety Modernization Act of 2011 (FSMA) has for the first time, specifically put the onus on importers to have a program to verify that the food products they are bringing into this country are safe. The idea behind FSMA is to change FDA regulatory enforcement and focus to more of a preventative approach, instead of reactionary. These new requirements include risk-based controls, foreign supplier verification program, certification, and audits. A brief overview of the requirements may be found here.

I’ve summarized the requirements relevant to your Bioterrorism Act Registration below, so you can be sure your registration […]

By Jennifer Diaz|2013-01-22T21:40:00-05:00January 22, 2013|Food, FSMA, U.S. Food and Drug Administration (FDA)|0 Comments

FDA Extends Until January 31 for Food Facilities to Re-Register

Below are the latest and greatest updates regarding compliance with the FDA’s Food Safety Modernization Act (FSMA). It includes background on FSMA, an update from FDA with 2 new guidance documents, FDA’s extension to file biennial registrations, and an update on FDA using its enforcement power to suspend a facilities registration – meaning they can NOT import into the U.S. FSMA Background

FSMA, enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d]. The registration requirements in section 415 of the FD&C Act apples to domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. Section 102 of FSMA amended section 415 of the FD&C Act in relevant part to provide that food facilities required to register with FDA must renew their registrations with FDA every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year, otherwise, their registration will be cancelled by the FDA.

Re-Inspection Fees

Importantly, please note that facilities will be charged reinspection fees by the FDA. Reinspections are follow-up inspections conducted by the FDA after a previous inspection by the FDA where the FDA identified non-compliance issues materially related to food safety. The purpose of the reinspection is to assure the issue has been remedied and food is now safely produced. Fees are adjusted […]

By Jennifer Diaz|2022-07-08T15:53:43-04:00December 18, 2012|Bioterrorism Act, Enforcement, FSMA, U.S. Food and Drug Administration (FDA)|0 Comments

Jennifer Diaz Joins Governor Rick Scott in Addressing Businesses in Bogota

On December 4, 2012, I will address companies in Bogota, Colombia to discuss the “Top 10 Tips When Importing into the U.S. to Ensure Compliance.” My particular topic will go into depth on the top costly mistakes I’ve seen importers make, and most importantly, how to avoid them. I will go into compliance with the newly enacted Free Trade Agreement and compliance with other federal government agencies (like U.S. Food and Drug Administration (FDA), Consumer Product Safety Commission (CPSC), and more. Importantly, I will address how to effectively deal with the U.S. government, should you have trouble while importing.

The conference is in conjunction with Enterprise Florida’s Trade Mission to Colombia led by Florida’s Governor Rock Scott. The purpose of the half day conference is to address the current environment of big business opportunities in Florida, especially in light of the new U.S.-Colombia Free Trade Agreement (FTA).

Other panels include: The U.S. Economy and Investment Opportunities; Rules of Origin & Trade Facilitation (Compliance with the new FTA); Business Opportunities in Infrastructure and Utilities. All panelists will be available for question and answer sessions as well.

Colombia is the fifth largest economy in Latin America, with a population of approximately 45 million. During the last decade, improvements in security and political stability have fostered economic growth and a secure business climate. With 4 percent GDP growth in 2010 and an estimated 4.6 percent growth in 2011, the Colombian market presents unbounded opportunities […]

By Jennifer Diaz|2012-11-30T22:00:00-05:00November 30, 2012|Free Trade Agreement, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|0 Comments

Biennal Registration Requirement is Up and Running!

Biennial Registration Renewal for Food Facilities is now available, as of October 22, 2012.

Here’s what you need to know about FDA’s new FSMA requirement on Bioterrorism Act registrations. Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA.

The Food Safety Modernization Act of 2011 (FSMA) has for the first time, specifically put the onus on importers to have a program to verify that the food products they are bringing into this country are safe. The idea behind FSMA is to change FDA regulatory enforcement and focus to more of a preventative approach, instead of reactionary. These new requirements include risk-based controls, foreign supplier verification program, certification, and audits. A brief overview of the requirements may be found here.

I’ve summarized the requirements relevant to your Bioterrorism Act Registration below, so you can be sure your registration doesn’t lapse. If your not re-registered by December 2012, FDA will cancel your Bioterrorism Act registration and your […]

By Jennifer Diaz|2022-07-08T15:51:13-04:00October 11, 2012|U.S. Food and Drug Administration (FDA)|0 Comments

FDA Biennial Registration is Up and Running

Biennial Registration Renewal for Food Facilities is now available, as of October 22, 2012.

Here’s what you need to know about FDA’s new FSMA requirement on Bioterrorism Act registrations. Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA.

The Food Safety Modernization Act of 2011 (FSMA) has for the first time, specifically put the onus on importers to have a program to verify that the food products they are bringing into this country are safe. The idea behind FSMA is to change FDA regulatory enforcement and focus to more of a preventative approach, instead of reactionary. These new requirements include risk-based controls, foreign supplier verification program, certification, and audits. A brief overview of the requirements may be found here.

I’ve summarized the requirements relevant to your Bioterrorism Act Registration below, so you can be sure your registration doesn’t lapse. If your not re-registered by December 2012, FDA will cancel your Bioterrorism Act registration and your importations will be delayed.

New Biennial Registration Requirements
FSMA amended the Food, Drug & Cosmetic Act (FD&C Act) Section 415 to provide for biennial registration updates. Facilities which are required to register will have to re-register every 2 years, during the period beginning on October 1 (in this case, October 22) and ending on December 31 in even numbered years. This will first occur in October-December 2012.

Note that even facilities which are already registered with the FDA are still […]

By Jennifer Diaz|2022-07-08T15:52:37-04:00October 8, 2012|FDA Issues, Pre-compliance, U.S. Food and Drug Administration (FDA)|0 Comments