FDA Compliance Services
Get Your Company FDA Registered Today
Food, Beverage & Dietary Supplements
FDA registration is mandatory for all domestic and foreign food facilities involved in manufacturing, processing, packing, or storing food for consumption in the United States. This registration allows the FDA to quickly identify and contact facilities in the event of a public health concern. Key features include:
- Preparing and submitting your FDA facility registration
- Ensuring accuracy in facility details to avoid delays or errors
- Managing renewals during the biennial renewal period
- If you are a foreign facility, you must appoint a U.S. Agent to act as your official contact with the FDA. We provide professional U.S. Agent representation to facilitate compliance and communication.
- Acting as your official U.S. Agent for FDA communications
- Addressing any FDA inquiries or issues on your behalf
- Automatic reminders and tracking of renewal deadlines
- Updates to facility information, if necessary
- Proactive alerts for changes that may require action
Medical Device
If your company produces or distributes medical devices in the U.S., annual registration is mandatory. Firms involved in manufacturing, packaging, labeling, or reprocessing must also pay an annual fee. We manage the entire facility registration process, ensuring compliance with FDA requirements for medical devices (21 CFR Part 807). Key benefits include:
- Facility details entry, including activities and product categories
- Confirmation of registration completion with FDA registration number issuance
- U.S. Agent designation for foreign facilities
- FDA registrations for medical devices and cosmetics must be renewed annually between October 1 and December 31. We ensure on-time renewals
- We provide accurate device listing services aligned with FDA requirements
- FDA medical device listing submissions via FURLS
- Annual listing maintenance and resubmissions as required
Cosmetics
FDA’s new MoCRA regulations requires cosmetic manufacturers to register their facility and list their products. We manage the entire facility registration process, ensuring compliance with FDA requirements for cosmetics (FD&C Act). Although the FDA does not pre-approve cosmetic products, facilities must ensure compliant labeling and ingredient safety under FD&C Act standards to ensure they meet FDA regulations. Key features include:
- MoCRA facility registration
- Review of cosmetic product labels for FDA compliance
- FEI number service
- Product listing
- Proactive alerts for changes that may require action
- Small businesses are exempt from the registration and listing requirements if they meet certain criteria
- MoCRA requires the manufacturer of the cosmetic products to renew their facility registration every two years. We ensure on-time renewals
Drug Establishment
Drug establishment registration is the process by which firms notify the U.S. Food and Drug Administration (FDA) of the physical locations (establishments) where drugs are manufactured, prepared, propagated, processed, or imported for commercial distribution in the United States.
This requirement is grounded in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and codified under 21 CFR Part 207. The goal is to create a centralized, transparent system for the FDA to monitor and regulate the facilities responsible for producing or handling drug products distributed within the U.S. market.
Each registered establishment is assigned a Facility Establishment Identifier (FEI) number, which the FDA uses to conduct inspections, trace recalls, and facilitate import decisions. For example, a firm that fails to register could face an import refusal, as seen in numerous FDA warning letters published annually. Key Registration Information Required:
This requirement is grounded in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and codified under 21 CFR Part 207. The goal is to create a centralized, transparent system for the FDA to monitor and regulate the facilities responsible for producing or handling drug products distributed within the U.S. market.
Each registered establishment is assigned a Facility Establishment Identifier (FEI) number, which the FDA uses to conduct inspections, trace recalls, and facilitate import decisions. For example, a firm that fails to register could face an import refusal, as seen in numerous FDA warning letters published annually. Key Registration Information Required:
- Legal name and D-U-N-S (Data Universal Numbering System) number of the establishment
- Type(s) of business operation (e.g., manufacturer, repacker)
- Contact details for the responsible official
- U.S. Agent and importer details (for foreign firms)
- A list of all drug products manufactured or processed at the site
- Registration renewal occurs between October 1 and December 31 each year. We ensure on-time renewals
- Drug listing updates may occur at any time in the calendar year