National Agency for Food and Drug Administration and Control (NAFDAC)’s Post

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

Preparing a subject matter expert (SME) to face a USFDA (U.S. Food and Drug Administration) inspection or audit requires careful planning, thorough knowledge of regulatory standards, and strong communication skills. Here's a step-by-step guide to help SMEs prepare for such an event: You are also welcome to share your thoughts and practices. #inspection #USFDA

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

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

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

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

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:

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

An FDA inspection led to the discovery of “significant violations” at Tom’s of Maine manufacturing facility, which included infections causing bacteria in water used to make toothpaste and a black “mold-like” substance. The FDA said the brand also used the same water to rinse numerous pieces of equipment. On Nov 5, The Food and Drug Administration (FDA) outlined such violations in a warning letter sent to the parent company Colgate-Palmolive after the agency found disease-causing bacteria and mold-like and powdery substances in its products and facilities. According to the FDA, Tom's responded that it handles complaints with a "risk-based approach" and that individual complaints are not enough to deem a product inadequate. Follow for the latest updates. . . . #FDA #Inspection #Violations #Toothpaste #Safety #Health #Mold #Bacteria #ConsumerSafety #TomsofMaine #Colgate #ProductWarning #FDAInspection #Manufacturing #PublicHealth #Contamination #WaterSafety #QualityControl #HealthRisk #Cleanliness #Regulations #ConsumerAlert #FDAWarning #HealthMatters #News #WorldSpotlightNews

With QBD now is QBR...Quality by Risk assessment