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Devices that emit radiation, including X-ray machines, lasers, ultrasound equipment, tanning lamps, and microwave ovens, are regulated by the FDA under 21 CFR Parts 1000–1050. Manufacturers, importers, and distributors must comply with strict registration, reporting, and safety requirements to ensure public health and avoid regulatory enforcement actions. At XPRO AMERICA, we provide end-to-end [...]
Infant formula and baby foods are subject to strict FDA regulations to ensure safety, nutritional adequacy, and labeling accuracy for vulnerable populations. Manufacturers must comply with specialized review requirements, register facilities, and maintain adherence to nutrient content standards before marketing their products in the United States. At XPRO AMERICA, we provide comprehensive guidance [...]
Human Cells, Tissues, and Cellular/Tissue-Based Products (HCT/Ps) are highly regulated by the FDA to ensure safety, quality, and traceability. Facilities that manufacture, process, store, or distribute HCT/Ps must comply with 21 CFR Part 1271 requirements, including registration, listing, adherence to Good Tissue Practices (GTP), and inspection readiness. At XPRO AMERICA, [...]
The dietary supplements and nutraceuticals industry in the U.S. is highly regulated under 21 CFR Part 111 to ensure product safety, quality, and accurate labeling. Compliance with FDA regulations is mandatory for manufacturers, distributors, and importers, covering facility registration, labeling, Good Manufacturing Practices (GMP), and reporting new dietary ingredients (NDIs). [...]
The FDA regulates color additives and food contact substances (FCS) to ensure safety for consumers. Companies introducing new color additives or materials intended for contact with food must comply with rigorous FDA requirements, including premarket approval, notifications, and safety testing. At XPRO AMERICA, we provide end-to-end guidance for manufacturers, distributors, [...]
The FDA regulates blood and tissue products to protect public health and ensure safety, efficacy, and quality. Facilities such as blood banks, cord blood banks, and tissue establishments must comply with rigorous regulatory requirements, including registration, donor eligibility screening, labeling, and traceability documentation. At XPRO AMERICA, we provide comprehensive support [...]
The development and marketing of biologics and vaccines in the U.S. are tightly regulated by the FDA to ensure safety, efficacy, and quality. Compliance with regulatory requirements, including Biologics License Applications (BLA), Investigational New Drug (IND) submissions, and GMP standards, is essential for legal distribution and clinical trial approval. At [...]
The U.S. FDA regulates animal drugs, feed, and veterinary products to ensure the safety, quality, and efficacy of products for animals. Compliance with FDA regulations, including 21 CFR Part 514 and FSMA (Food Safety Modernization Act), is mandatory for manufacturers, distributors, and importers. Proper registration, labeling, and reporting are critical [...]
The production and distribution of alcoholic beverages in the United States are regulated by both the FDA and the Alcohol & Tobacco Tax and Trade Bureau (TTB). Compliance with FDA regulations ensures ingredient safety, while TTB governs labeling, taxation, and marketing. Manufacturers and importers must navigate this dual regulatory framework [...]
US FDA Food Facility Registration (FFR) is a mandatory requirement for all domestic and foreign facilities involved in the manufacturing, processing, packing, or storing of food and beverage products intended for consumption in the United States. This regulation, established under the U.S. Food Safety Modernization Act (FSMA), ensures that every [...]