CHAKRAPANI KVC GALTERIAN’s Post

In this article of the 2024 End-to-End Manufacturing Manual, my Foley colleagues discuss the 2024 Consumer Product Safety Commission and the U.S. Food and Drug Administration enforcement trends. Click below to read more! #Manufacturing #ConsumerProducts #FoodandBeverage

#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.

The #FDA has just updated its guidance on Remote Regulatory Assessments (RRAs), aiming to enhance oversight, reduce risk, and ensure public health regarding #food, #drugs, and #medicaldevices. RAAs are a major leap in modernizing enforcement processes for FDA-regulated products. #FDA #RegulatoryInnovation #PublicHealth https://lnkd.in/ejuVxV6A

Per new reporting from the Regulatory Affairs Professionals Society (RAPS), a panel of FDA's device experts offered up some tips on handling warning letter and 483 responses. Here's a quick distillation of their suggestions: • Understand that responding to a Form 483 is not mandatory, unlike a warning letter, which requires a response within 15 calendar days if you want your feedback to be considered before the warning letter is issued. • Be realistic and specific about what can be achieved within the given timelines. Overpromising can erode your credibility. • Include a detailed plan for corrective actions. Outline feasible timelines and specify steps for addressing the issues raised. • Be clear about the scope and timeframe of your corrective actions, especially when these involve extensive reviews or multiple products. • Emphasize the importance of root cause analysis in your response. Avoid rushing this process to meet a 15-day deadline if it compromises the quality of the analysis. • Follow your established internal processes for identifying root causes and implementing corrective actions. This helps in avoiding hasty decisions that could lead to further issues. • Clearly state immediate containment actions to mitigate any ongoing risks while longer-term corrective actions are being planned and implemented. ——— Having helped hundreds of firms manage their responses in light of warning letters and 483s, we'd add a few things here: 🔹 Make sure all documentation related to the response is clearly written and thoroughly checked for accuracy. Ambiguities or errors in response documents can lead to misunderstandings or a perception of incompetence or nonchalance. 🔹 Look back at previous interactions with the FDA, including past 483s or warning letters, to identify any recurring issues or patterns. Demonstrating awareness of historical issues and how they have been addressed shows your commitment to continuous improvement. 🔹 Make sure your employee training records are up-to-date. A lack of training is a common root cause cited during inspections, so demonstrating robust training practices can mitigate this concern. 🔹 Include a detailed follow-up plan in your response, indicating how you will monitor the effectiveness of the corrective actions over time. Include specific benchmarks for success and regular review points. ——— Before crafting or submitting a response, consider having it written or reviewed by external experts. Our clients often find that a fresh perspective from a regulatory expert with deep experience in crafting responses helps identify potential weaknesses or areas of non-compliance that internal teams might overlook. Talk to us if you ever find yourself needing to respond to the FDA. 🔗 https://lnkd.in/gQjmXHcM #fda #warningletter #form483

🚀 Unlock U.S. Market Opportunities with FDA Registration! 🇺🇸🍇 Are you a dry fruit exporter looking to expand your business into the lucrative U.S. market? 🌍 One essential step is FDA registration! The Food and Drug Administration (FDA) regulates imported food products, and ensuring your compliance is key to seamless trade. Why FDA Registration? ✅ Legal entry into the U.S. market ✅ Builds credibility with buyers and partners ✅ Ensures product safety and consumer trust What’s the process? Get your facility registered with the FDA Ensure compliance with FDA regulations on packaging, labeling, and safety standards. Stay updated on biannual renewals Navigating this process can be tricky, but with the right guidance, it's simpler than you think! At Prime Consultants And Trainers, we specialize in helping businesses like yours secure FDA registration and achieve smooth market entry. 🛠️ Whether you're a seasoned exporter or just starting out, securing your FDA registration can give your business a competitive edge. Need assistance with the process? Let’s connect and get your business FDA-ready! #PrimeConsultants #FDARegistration #DryFruitExport #GlobalTrade #USMarket #FoodSafety #Compliance #ExporterTips Contact Us: Cell No: 03202677097 Website Link: https://lnkd.in/eK2tDT_m

🚨 FDA Recall Summary Report Week of March 29, 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

Everyone talks about the #FDA, and every pharma employee gives their best efforts during an #FDA inspection. But what is the FDA? What is its history? The revolution that led to the establishment of the FDA can be traced back to the novel The Jungle, written by Upton Sinclair. The Hi"story" Behind the FDA Upton Sinclair's #The_Jungle, published in 1906, exposed the unsanitary conditions and unethical practices in Chicago’s meatpacking industry. While the novel aimed to highlight the struggles of workers, it shocked the public with vivid descriptions of contaminated meat and food safety violations. This public outrage led to significant reforms, including the passage of the Pure #Food_and_Drug_Act (1906) and the #Meat_Inspection_Act (1906), which laid the foundation for the FDA. Over time, the FDA evolved into one of the most influential regulatory authorities in the world, ensuring the safety, efficacy, and quality of food, drugs, and medical devices. Sinclair summarized this shift by saying, “I aimed at the public's heart, and by accident I hit it in the stomach.”

🚨 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

🚨 Attention Importers! 🚨 The FDA has just released new guidance on the Voluntary Qualified Importer Program (VQIP)! 🌎📦 This program is designed to expedite the entry of your imported food products into the U.S. — but it’s voluntary. Participating in VQIP could mean faster processing, fewer inspections, and smoother operations for your business. 🕒✅ Here’s the key takeaway: • VQIP is designed to streamline the import process. • Participation is voluntary, but can offer benefits for qualified importers. • Guidance provided is non-binding but outlines the FDA’s current thinking. Want to learn more and see if your products qualify? Check out the FDA’s full guidance! 📑 #FDA #VQIP #Importers #FoodSafety #SupplyChain #FDAImportGuidance #ImportProcess #FoodIndustry #Regulations