GOCA consulting services

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The FDA frequently redacts parts of warning letters posted for public view.

FDA Warning Letters

La entrada FDA warns companies about seafood, import and preventative control violations se publicó primero en GOCA consulting services.

Salmonella onion outbreak is over, but FDA continues investigation.

GOCA — Mon, 07 Feb 2022 15:09:19 +0000

FDA officials continue to investigate a Salmonella Oranienburg outbreak attributed to whole fresh onions from Mexico, the outbreak has ended with more than 1,000 people sickened. A total of 1,040 people from 39 states had been infected. The Salmonella outbreak has remained from May 31, 2021 through January 1, 2022.

FDA continues to work with the U.S. importers, ProSource Produce LLC and Keeler Family Farms to determine if adequate precautions were taken for foreign suppliers. Some of the onions were sold in unmarked bulk containers at retailers.

“In September 2021, as part of the ongoing investigation to determine the illness-causing product, FDA’s import operations implemented enhanced Salmonella screening for onions imported into the United States,” according to an FDA statement.
“As a result of this outbreak, FDA initiated domestic on-site investigations, as well as Foreign Supplier Verification Program (FSVP) inspections of domestic companies that imported onions from the state of Chihuahua, Mexico. By inspecting these U.S. importers, FDA can determine whether they are in compliance with applicable FSVP requirements, including conducting certain risk-based activities to verify that imported food meets U.S. safety standards.

FDA intends to consider using additional tools, such as screening and sampling of imports, during the upcoming growing season.
On October 20, 2021, ProSource Produce LLC issued a recall. On October 22, 2021, Keeler Family Farms issued. Several companies issued additional recalls of onions packaged under different brand names and used as ingredients in other foods.

La entrada Salmonella onion outbreak is over, but FDA continues investigation. se publicó primero en GOCA consulting services.

Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act

GOCA — Wed, 26 Jan 2022 18:37:18 +0000

The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables the FDA to better protect public health by helping to ensure the safety and security of the food supply. It requires FDA to promulgate food safety rules that focus on preventing food safety issues rather than relying on detecting issues and reacting to them after they occur. FSMA recognizes that FDA has previously established a preventive control type regulation for fish and fishery products (Title 21, Code of Federal Regulations (21 CFR) part 123, the seafood HACCP regulation) based on the Hazard Analysis and Critical Control Point (HACCP) concept. See FSMA §§ 103(a), 103(f), 105(d), and 301 (§§ 418(j) and 805(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 350g(j), 350g note, 350h note, and 384a(e))). The seafood HACCP regulation requires seafood processors to identify food safety hazards that are reasonably likely to occur and to develop plans for the control of those hazards.

In addition, the seafood HACCP regulation requires importers of certain seafood products to comply with requirements designed to help ensure that these imported products are processed in accordance with the seafood HACCP regulation.

Importantly, several of the regulations that FDA has issued under FSMA provide exemptions related to the seafood HACCP regulation. This guidance, first issued in August 2017, addresses those exemptions, and also provides information about the seafood HACCP regulation in connection with the FSMA regulations.

Though not the subject of this guidance, we also note that some seafood products are also subject to 21 CFR part 113 (Thermally Processed Low-Acid Foods Packaged in Sealed Containers). Certain FSMA regulations provide additional exemptions related to part 113.

This guidance summarizes how the following FSMA regulations affect processors and importers subject to the seafood HACCP regulation:

21 CFR part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (CGMP & PC Regulation)
21 CFR 1, subpart L, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (the FSVP Regulation)
21 CFR 1, subpart M, Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications (Accredited Third-Party Certification Regulation)
21 CFR part 121, Mitigation Strategies To Protect Food Against Intentional Adulteration (the IA Regulation)
21 CFR 1, subpart O, Sanitary Transportation of Human and Animal Food (the ST Regulation)

Download the Guidance

La entrada Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act se publicó primero en GOCA consulting services.

First warning letters from FDA for non-compliance with FSVP regulation

GOCA — Thu, 16 Dec 2021 08:40:10 +0000

The FSVP regulation requires importers to perform certain risk-based activities to verify that the human and/or animal food they import into the United States has been produced in a manner that meets U.S. food safety standards.

FDA is sending the first warning letters to companies that do not comply with the Foreign Supplier Verification Program (FSVP) regulations. Companies receiving the warning letters will have 15 days to respond to FDA.

FDA notified a Washington importer for failure to have FSVP documentation for several imported food products. FDA’s inspection revealed that the company was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.

All importers are required to verify that their foreign suppliers of food and feed products comply with applicable FDA safety standards.

FDA Warning letter.

La entrada First warning letters from FDA for non-compliance with FSVP regulation se publicó primero en GOCA consulting services.

9th FDA Allergen: Sesame

GOCA — Thu, 08 Jul 2021 10:43:30 +0000

Under the FASTER Act of 2021, sesame is being added as the 9th major food allergen effective January 1, 2023. Until that time, manufacturers do not have to list it as an allergen, although in most cases it must appear in the ingredient statement. An exception is when sesame is part of a natural flavoring or spice. Another exception is when sesame is not in the common or usual name of a food (e.g., tahini, which is made from sesame seeds). In November 2020, to help consumers who are allergic or sensitive to sesame to avoid these products, the FDA issued a draft guidance to encourage manufacturers to voluntarily declare sesame in the ingredient list when it is used as a “flavoring” or “spice” or when the common or usual name (such as tahini) does not specify sesame. The guidance is intended to help protect consumers who are allergic to sesame by encouraging manufacturers to identify all ingredients that contain sesame right now.

La entrada 9th FDA Allergen: Sesame se publicó primero en GOCA consulting services.

FDA Seeks Innovative Food Traceability Tools and Opens a Dialogue on Advancing Food Safety with Technology

GOCA — Wed, 26 May 2021 10:43:05 +0000

A goal of the FDA’s New Era of Smarter Food Safety initiative is to achieve end-to-end traceability – from source to table – throughout the food safety system. The FDA wants to explore ways to encourage firms to voluntarily adopt tracing technologies and ways to harmonize tracing activities, working toward outcomes that are achievable for all sectors of the food system.

However, the affordability of such technologies, particularly for smaller companies, can be a barrier to adopting tech-enabled traceability systems. To achieve end-to-end food traceability, accessible tracing solutions are needed. One of the goals in the New Era of Smarter Food Safety blueprint is to encourage the development of creative financial models that are low- to no-cost solutions, proportional to benefits derived from participating, and enabling human and animal food operations of all sizes to participate in a scalable, cost-effective way.

Toward these efforts, the FDA will be launching the FDA New Era of Smarter Food Safety Low- or No-Cost Tech-Enabled Traceability Challenge as part of the America COMPETES Reauthorization Act of 2010 (COMPETES Act). The primary goal of this challenge is to encourage stakeholders, including technology providers, public health advocates, entrepreneurs, and innovators from all disciplines to develop traceability hardware, software, or data analytics platforms that are low-cost or no-cost to the end user.
Access to food traceability solutions that utilize affordable economic models may encourage widespread adoption.

The submission period for the challenge will run from June 1 at 8 am ET through July 30, 2021 at 5 pm ET and the winners will be announced in late August. In the months following the challenge, winners will be given the opportunity to present the solutions they developed in a webinar that’s available to the public.

Click here to sign up for more informatio.

La entrada FDA Seeks Innovative Food Traceability Tools and Opens a Dialogue on Advancing Food Safety with Technology se publicó primero en GOCA consulting services.

Beginning the 2º phase of Smarter Food Safety, food traceability.

GOCA — Wed, 10 Feb 2021 18:47:18 +0000

The U.S. Food and Drug Administration has launched the second phase of its Artificial Intelligence (AI) Imported Seafood Pilot program. The pilot is scheduled to run from February 1, 2021 through July 31, 2021, and the agency does not expect any significant service interruptions to industry and seafood import processers.

The pilot is designed to enhance and improve the agency’s ability to quickly and efficiently identify imported seafood products that may pose a threat to public health. This is especially important since the United States imports upwards of 94 percent of its seafood supply.

In 2019, the agency launched the first phase of the pilot, an analytical proof of concept, to examine the use of Machine Learning (ML) to target violative seafood shipments. The analysis demonstrated the potential for AI to assist FDA in ensuring the security and safety of the nation’s food supply, specifically imported seafood. Machine learning is a type of AI that makes it possible to rapidly analyze data, automatically identifying connections and patterns in data that people or even the agency’s current rules-based screening system cannot see.

2º phase of Smarter Food Safety

La entrada Beginning the 2º phase of Smarter Food Safety, food traceability. se publicó primero en GOCA consulting services.