US FDA Registration In Mumbai

FDAs 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. 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.

Be prepared for FSMA inspections. Tailored to meet your needs, our FSMA audits are adapted to each site, focus on specific requirements not already covered in your food safety systems, and can include bespoke requirements as well as hazard-specific controls:

FSMA pre-certification audits to prepare for accredited FSMA certification

Gap assessments and gap audits

Food defense (intentional adulteration) audits

Compliance audits for intentional adulteration (IA) rule

Vulnerability assessment of facilities

Preventive controls audits

FSMA addendum audits for GFSI standards

FSMA Importer Compliance Audits

Foreign Supplier Verification Program (FSVP) compliance audits

Supplier risk assessments

Supplier preventive controls audits

With FSMA, the food industry is shifting to a proactive culture that focuses on preventing contamination events, rather than reacting after the fact. 

CDG can help you ensure compliance across your food facilities and supply chain with FSMA audit, testing, training and technical services.