Paul Backovich’s Post

FDA issues warning letters to mushroom and produce importers for critical safety violations By News Desk on November 4, 2024 The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. 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 has issued warning letters to two produce importers, Future Best Trading Inc. and Paso Real Produce LLC, for major violations under the Foreign Supplier Verification Program (FSVP). Both firms received a Form FDA 483a, detailing their serious compliance lapses. https://lnkd.in/gHXRpG_7

Is your food packaging ready for FDA evaluation? No longer one-and-done, the FDA’s newly proposed post-market assessment for chemicals in food also extends to packaging components already cleared by the agency. And its post-market enforcement program may include inspections of food packaging manufacturing plants. Are you and your suppliers prepared? 📖 Read Keller and Heckman LLP Partner George Misko’s latest article on how these new changes could impact your business: https://lnkd.in/evNGsXQh #KellerandHeckman #FDA #FoodSafety #Compliance

FDA #Detentions occur when the U.S. Food and Drug Administration holds imported #food products that may violate safety standards. Reasons for detention include #contamination, #mislabeling, or failing to meet regulatory requirements 🛑 🥑 🥕 If a company's products are detained, the firm must act promptly. First, they should review the detention notice to understand the specific violations. Next, they should gather documentation and evidence to demonstrate #compliance with #FDAstandards. This may include lab tests, production records, or third-party certifications. 👉 https://lnkd.in/eggsik7W Engaging with an #FDAcompliance expert can help navigate the process. Companies should respond to the FDA with a detailed corrective action plan, addressing the issues and outlining measures to prevent future violations. Timely and thorough communication is key to resolving detentions and ensuring the swift release of products. #FDA #foodsafety #compliance #importexport #regulations #foodindustry #productsafety #USDA #foodregulations #foodtesting #foodlaboratory Paulina Gastelum Laura Thomas Kevin Lewellyn Jeff Briceño-Castillo Brian McGillivray Justine Jannone Monique Alvarado Dhairya Patel Miguel Valero Ramón Bouza Deaño José Luis Ganivet Mateo José Acosta Llinares Mario Reyes

PRODUCT RECALL: A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective. One of the Critical arena of Product History which will call for Manufacturers attention to address on Top Priority. USFDA has a Manual called "RECALL PROCEDURES" under Chapter 7 of Regulatory Procedure Manual. Very Much valuable & Worthy Document to read. Courtesy: USFDA

In a continuation of the US Food and Drug Administration's efforts to conduct post-market reviews evaluating the continued use and safety of chemicals authorized in its regulations, the agency is removing old clearances for food-contact materials. Read more here: https://ow.ly/rQw950Uh4FK

Risk based evaluation and approach is an excellent and necessary approach for every GMP decision

🚨 FDA Recall Summary Report Week of November 03, 2024 Does your facility have an EFFECTIVE Recall Management Plan❓ Recalls are given a Class assignment by the food company which initiated the event based on FDA Guidance 💡 Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 💡 Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 💡 Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. We have firsthand experience interfacing with Federal regulators during recall situations. CONTACT US for specialized recall solutions!  📞 (414) 839-4498 💻 Solutions@foodsafetymuse.com #foodsafety #foodandbeverage #foodindustry #foodsafetyculture #consultants #qualityassurance #foodmanufacturing #compliance #cannabis #fda #foodsafetymuse

In case you were wondering why/how #FDA 483's can now include phrases like: "there is no risk assessment"... or "the risk of [xx] has not been evaluated", from API to Finished Product, check out Sec. 711 of the Food and Drug Administration Safety and Innovation Act (2012) for the background:

#HaynesBoone attorneys Suzie Trigg, Carleigh Lenz and Luke Nguyen explore how recent key changes to the updated FDA standards could impact food labeling in the years ahead. Read more about the updated standards and compliance timeline at the link in the comments.

🚨 FDA Recall Summary Report Week of September 08, 2024 Does your facility have an EFFECTIVE Recall Management Plan❓ Recalls are given a Class assignment by the food company which initiated the event based on FDA Guidance 💡 Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 💡 Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 💡 Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. We have firsthand experience interfacing with Federal regulators during recall situations. CONTACT US for specialized recall solutions!  📞 (414) 839-4498 💻 Solutions@foodsafetymuse.com #foodsafety #foodandbeverage #foodindustry #foodsafetyculture #consultants #qualityassurance #foodmanufacturing #compliance #cannabis #fda #foodsafetymuse