From Concept to Shelf
Our experts can make your Company and Products Compliant with FDA Regulations.
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Register your Establishments
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Manufacture or Import Products
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List your Products Fast
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Speak with an Expert Today
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Standard Operating Procedure (S.O.P.)
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Inspection 483, We can Help!
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Establishment Registration
As easy as filling out our registration form. You will need to have the following information available to register:
- DUNS Number
- Company Name and Address
- Contact Name and Email
- Facility Operation
FEI
NDC(Labeler Code)
Adding the Facility Establishment Identifier (FEI), after registration is completed, is a simple process to complete with our cloud application.
Also, requesting a Labeler Code (NDC) is as easy as pressing the submit button with our cloud application.
Product Listing
Anyone who has spent time trying (and often failing) to get their products listed with the FDA, knows how daunting it can be.
We offer a simple solution for both Manufacturers, Repackagers, Relabelers and Pharmacies. As a Repackager/Relabeler your options include Zero Data Entry Listing™
Establishment Registrations
We can turn days of frustration into minutes of work.
We have the expertise and proprietary software designed specifically to register both establishments and drugs with the FDA.
Medical Devices Listing and Facility Registration is another area where our experts can help you make good use of your time.
Ready to Start?, fill our registration form.Register Now
Once registered you can solicit a new Labeler Code(NDC), Request or add your Facility Establishment Identifier (FEI) to your Drug Establishment Registration or List/Edit/Remove Product Listings.
Or simply Contact Us
FEI / NDC
What is FEI?
Facility Establishment Identifier (FEI) is a Ten (10) digit number unique identifier issued by FDA to track and monitor inspections of regulated establishments or facilities.
FEI is part of the required information to meet self-identification in the Generic Drug User Fee Amendments of 2012 (GDUFA.)
What is Labeler Code (NDC)?
NDC labeler code is a ten digit unique identifier number for drugs, The NDC is divided into three segments and they can be arranged in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1.
- The 1st segment of the NDC is the Labeler code, it identifies the establishment; FDA will assign this number and will be unique for each establishment (manufacturer, packer, labeler etc...).
- The 2nd segment identifies the drug (strength, dosage and formulation).
- The 3rd segment identifies the package size and package type.
- The second and third segments are assigned by the labeler.
The Labeler code request to the FDA should be submited in SPL (Structured Product Labeling) format via FDA ESG (Electronic Submission Gateway).
Who is required to register
Who Is Required to Self-Identify? The following types of generic industry facilities, sites, and organizations are required to self-identify with FDA:
- 1. Facilities that manufacture, or intend to manufacture, human generic drug APIs or FDFs, or both.
- 2. Sites and organizations that package the FDF of a human generic drug into the primary container/closure system and label the primary container/closure system.
- 3. Sites that are identified in a generic drug submission and pursuant to a contract with the applicant remove the drug from a primary container/closure system and subdivide the contents into a different primary container/closure system.
- 4. Bioequivalence (BE)/bioavailability (BA) sites that are identified in a generic drug submission and conduct clinical BE/BA testing, bioanalytical testing of samples collected from clinical BE/BA testing, and/or in vitro BE testing.
- 5. Sites that are identified in a generic drug submission and perform testing of one or more attributes or characteristics of the FDF or the API pursuant to a contract with the applicant to satisfy a current good manufacturing practice (CGMP) testing requirement (excludes sites that are testing for research purposes only).
What Is the Penalty for Failing to Self-Identify?
Under GDUFA, if a facility fails to self-identify, all Finished Dosage Forms(FDF) or Active Pharmaceutical Ingredients (API) products manufactured at the facility and all FDFs containing APIs manufactured at the facility will be deemed misbranded. It is a violation of federal law to ship misbranded products in interstate commerce or to import them into the United States. Such violations can result in prosecution of those responsible, injunctions, or seizures of the misbranded products. Products that are deemed misbranded because of failure of the facility to self-identify are subject to being denied entry into the United States.
The idea behind the use of identifying numbers is to be able to track facilities, in the interest of consumer protection. The Facility identifiers started in 2000. The old CFN are retained. The main purpose is to ensure maintenance of an establishment’s record of operations & products.
Passage of Food and Drug Administration Safety and Innovation Act (FDASIA) signed July 9, 2012 specifies use of a Unique Facility Identifier
Testimonials
Hoff W.
C.E.OA-S Medication Solutions
We have found FDA Consulting’s Drug Product Listing solution to be fast and accurate. Their team is both highly innovative and responsive. I believe it to be the best solution in the industry.
OVER 20 THOUSAND PRODUCTS LISTED
AND COUNTING....Harkins, S
Managing DirectorUnit Dose Services, LLC
We have utilized FDA Consulting Group to maintain our compliance standards related to the listing of repackaged NDC numbers with the FDA. Their process is simple, accurate and effective. We are very happy with the decision to outsource this aspect of our business to create internal efficiencies as well as to maintain our compliance with the ever changing regulatory agencies.