US FDA Registration in Bangalore

Listing ID #1109658

U.S. FDA food facility registration is required for all companies that manufacture, process, pack, or store food, beverages, or dietary supplements that may be consumed in the united states. Food facilities located outside the united states must also designate a u.s. Agent for fda communications. The u.s. Agent for fda communications serves a different function than an importer, customs broker or commercial distributor. Fda sends communications to the designated u.s. Agent, including information regarding inspections, often requiring an immediate response. Registrar corp's regulatory specialists will handle a foreign facility's fda communications professionally as a u.s. Agent. the u.s. Fda is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the united states. For devices that are exempt from premarket notification, manufacturers (both domestic and non-u.s.) and initial distributors (importers) of medical devices must register their establishments with the u.s. Fda. the u.s. Fda regulates drug products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and intended to affect the structure or any function of the body of humans or animals. Registrar corp provides registration, u.s. Agent, and compliance assistance for u.s. And non-u.s. Companies in the drug industry. the u.s. Fda regulates cosmetic products intended for use in the united states and the state of california has imposed additional requirements for cosmetic products intended for use in california. Registrar corp provides registration, ingredient statement filing, and labeling assistance for u.s. And non-u.s. Companies in the cosmetic products industry. Companies shipping products to the united states may find their shipments subject to "detention without physical examination" by u.s. Fda. Products subject to detention without physical examination are held at the port of entry while u.s. Fda performs additional scrutiny, testing, and analysis. Delays from detention without physical examination may be lengthy for businesses anxious to deliver products on schedule. fda’s activities in india are to ensure that food and medical products exported from india to the u.s. Are safe, are good quality, and are effective; these efforts include obtaining better and more robust information to help fda officials in the various fda headquarter offices and centers and at the borders make better decisions about products from india that are being developed for the u.s. Market. This includes products being reviewed for marketing authorization in the u.s., and that are already on the u.s. Market. To this end, fda activities in india include: engaging with indian counterpart regulatory authorities to ensure the timely exchange of information regarding clinical trials that are conducted that support marketing applications in the u.s.; partnering with indian counterpart agencies on various bilateral and regional capacity building initiatives; working with regulated product industries in india that wish to export their products to the u.s. To assure their understanding of our standards and expectations regarding fda-regulated products; coordinating and collaborating daily on product quality and safety issues with other u.s. Government agencies that have complementary missions to assess conditions and events in those areas that might have an impact on the safety and quality of fda-regulated products being exported to the u.s.; increased fda inspections of relevant high-risk facilities; and by working with private- and public-sector entities that wish to engage with fda on third-party certification efforts regarding these products.