frequently asked questions


WORKING WITH CITRON
What is Citron?

How can Citron assist me and my business?

Is Citron a full-service FDA regulatory consulting firm?

Where is Citron headquarters?

Does Citron offer global or international services?

Does Citron employ FDA regulatory experts?

What consulting services does Citron offer?

Can Citron help me become ISO certified?

Does Citron offer assistance with internal audits?

How can Citron assist with submissions to the FDA?

How does Citron manage my data and submissions to the FDA?

How will Citron help me gain compliance with the FDA?

How can Citron help with establishment registration?

How can Citron help market my medical device?

Can citron assist me with patents and trademarks for my products?

Can Citron assist my company with writing regulatory SOPs?

How does Citron protect my proprietary information?

Can Citron help me produce a COA?

Can Citron help me produce an SDS?

Does Citron offer label review services?

What are your fees for drug listing?

What are your fees for food and beverage listing?

What are your fees for medical device listing?

What are your fees for colorants and pigments listing?

What are your fees for NDC number assistance?

What are your fees for colorants and pigments listing?

Are these solutions really cost effective?

What are your fees for colorants and pigments listing?

Who should I identify in my company as the responsible person?

REGULATORY - registration

What is my company responsible for?
Company responsibilities will vary based on the goals you would like to accomplish, the different products you are processing or manufacturing and the scope of your companies work. Schedule a consultation with a Citron Professional in order to get a full understanding of what your company is responsible for.
What should I know about the annual reporting process?
HD video calls & conferences.
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What are the requirements for registration with the FDA? 
FDA registration is the basic requirement for domestic and foreign establishments that manufacture or market food, drug, API, medical devices, or cosmetic products in the USA. Companies that manufacture, process, pack, or store these products in the United States may be required to register with the FDA.
How much is the registration fee?
Registration fees will vary depending on the number of products, businesses, devices, etc. that you would like to register.
How much time is required to make submissions for registration?
The FDA will take 6-10 months to review all of the data submitted and either accept or deny the submission.
How much time is required to make submissions for registration?
The FDA will take 6-10 months to review all of the data submitted and either accept or deny the submission.
When should I self identify to the FDA?
The FDA will take 6-10 months to review all of the data submitted and either accept or deny the submission.
How much time will it take to self identify my facility?
The FDA will take 6-10 months to review all of the data submitted and either accept or deny the submission.
How can I verify my self identification status?
The FDA will take 6-10 months to review all of the data submitted and either accept or deny the submission.
What about fees for self-identification?
The FDA will take 6-10 months to review all of the data submitted and either accept or deny the submission.
What information do I have to provide for listing my products with the FDA?
The FDA will take 6-10 months to review all of the data submitted and either accept or deny the submission.
When do we need to renew our registrations?
Annually.
What are the fees for establishment registration?
Annual Establishment Registration Fees change annually. For 2023 the current registration fee costs $6,493 to register directly with the FDA.
Are there any exemptions for establishment registration?
All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups in FY 2023.
How long will it take for establishment registration?
All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups in FY 2023.
Does the FDA issue certification for registration?
US FDA is not issuing a registration certificate, nor does US FDA recognize a registration certificate issued by a private business. As your US FDA agent, Citron will verify the registration and obtain an FDA registration certificate for your records.
What information is required for establishment registration?
US FDA is not issuing a registration certificate, nor does US FDA recognize a registration certificate issued by a private business. As your US FDA agent, Citron will verify the registration and obtain an FDA registration certificate for your records.
Who is my FDA US Agent?
US FDA is not issuing a registration certificate, nor does US FDA recognize a registration certificate issued by a private business. As your US FDA agent, Citron will verify the registration and obtain an FDA registration certificate for your records.
What are the regulatory requirements for life science companies?
US FDA is not issuing a registration certificate, nor does US FDA recognize a registration certificate issued by a private business. As your US FDA agent, Citron will verify the registration and obtain an FDA registration certificate for your records.
What does ‘responsible person’ mean according to the FDA?
US FDA is not issuing a registration certificate, nor does US FDA recognize a registration certificate issued by a private business. As your US FDA agent, Citron will verify the registration and obtain an FDA registration certificate for your records.
Who should I identify in my company as the responsible person?
US FDA is not issuing a registration certificate, nor does US FDA recognize a registration certificate issued by a private business. As your US FDA agent, Citron will verify the registration and obtain an FDA registration certificate for your records.
Are standard operating procedures (SOPs) an important part of compliance?
US FDA is not issuing a registration certificate, nor does US FDA recognize a registration certificate issued by a private business. As your US FDA agent, Citron will verify the registration and obtain an FDA registration certificate for your records.

REGULATORY - COSMETIC (MOCRA)


What are FDA cosmetic labeling requirements?
All labels must be designed and applied to devices and containers so that the labels will remain in place and legible during the customary conditions of distribution, storage, and use. Likewise, other labeling, such as user instructions, should remain legible during customary storage and use.
What are FDA listing requirements for Cosmetics?
MoCRA requires that the responsible person for each cosmetic product offered for distribution in the U.S. provides the FDA with listing information for the product, including an ingredient list and the name/place of business of manufacture. Under the law, a “responsible person” means the manufacturer, packer or distributor of a cosmetic product whose name appears on the label of the product. Compliance for existing cosmetic products is required by Dec. 29, 2023. For new products marketed after the law’s effective date, manufacturers have 120 days after marketing has commenced in interstate commerce. Listings must be updated annually.
Can FDA Inspect cosmetic manufacturers?
FDA can and does inspect cosmetic manufacturing facilities to assure cosmetic product safety and determine whether cosmetics are adulterated or misbranded under the FD&C Act or FPLA.
What is the new MOCRA bill about?
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA's authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. C
What are the registration requirements for the new MOCRA bill?
MoCRA requires registration of each facility (domestic or foreign) that “manufactures or processes” cosmetic products for distribution in the U.S. Retailers, salons and private label distributors, among others that do not engage in such activities, do not need to register their facility. Compliance by existing facilities is required by Dec. 29, 2023. New facilities that begin manufacturing cosmetic products after the law takes effect will have 60 days to register after commencing operations. Registration must be renewed biennially thereafter.
Who needs a cosmetic listing?
Any manufacturer or processor of cosmetic and/or topical products, particularly those that include colorants or pigments are required to list their products with the FDA.
What are the registration requirements for the new MOCRA bill?
MoCRA requires registration of each facility (domestic or foreign) that “manufactures or processes” cosmetic products for distribution in the U.S. Retailers, salons and private label distributors, among others that do not engage in such activities, do not need to register their facility. Compliance by existing facilities is required by Dec. 29, 2023. New facilities that begin manufacturing cosmetic products after the law takes effect will have 60 days to register after commencing operations. Registration must be renewed biennially thereafter.

REGULATORY - OVER THE COUNTER DRUG (OTC)


What are FDA drug listing requirements for new drugs?
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What are FDA drug listing requirements for bulk drugs?
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What is a drug master file?
Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. They: Allow parties to reference material without disclosing DMF contents to those parties.
How can Citron help me with drug listings?
Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. They: Allow parties to reference material without disclosing DMF contents to those parties.
How much time will drug listing take?
Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. They: Allow parties to reference material without disclosing DMF contents to those parties.
How much time does it take to obtain an NDC number?
Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. They: Allow parties to reference material without disclosing DMF contents to those parties.
What is an NDC number?
Drugs are identified and reported using a unique, three-segment number called the National Drug Code (NDC) which serves as the FDA's identifier for drugs.
Who needs a drug listing?
Any manufacturer or processor of prescription and OTC topicals, supplements or oral medications that include active ingredients at a percentage at or above the FDA requirements for drug classification must list their product as a drug with the FDA.
What is an NDC labeler code?
The NDC labeler code is a 5 digit number assigned by the FDA, this is a unique number for each labeler. The labeler code represents the establishment or labeler. The NDC Number (National Drug Code) is a unique 3 segment 10 digit number which identifies the drug.
What information should be included for ANDA?
An ANDA lists the new drug's established name, trade name (if any), chemical name, dosage form(s), and strength(s), route of administration, and proposed use.
What is the time frame for approval for ANDA applications?
Within 180 days of initial receipt of an ANDA application.
How much is ANDA fee?
Projected fees for 2024 are $252,453
Who should file ANDA?
Projected fees for 2024 are $252,453
What Is a generic drug?
A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as the brand-name medicine. In other words, you can take a generic medicine as an equal substitute for its brand-name counterpart.

REGULATORY - FOOD & BEVERAGE


What are FDA listing requirements for food and beverages?
Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA.
What are US FDA labeling requirements for food and beverages?
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What are US FDA food and beverage regulations?
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What is the FDA biennial registration renewal period for food facilities?
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Does each food, beverage or dietary supplement require separate registration?
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How much time is required for food or beverage facility registration?
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Online store.
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SEO-ready.
Your websites are pre-optimized and SEO-friendly with minimal tweaks required from you.

REGULATORY - MEDICAL DEVICE


What are FDA listing requirements for medical devices?
Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA. This process is known as establishment registration (Title 21 CFR Part 807).

REGULATORY - NON-DIETARY SUPPLEMENTS


What are FDA listing requirements for non-dietary supplements?
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SEO-ready.
Your websites are pre-optimized and SEO-friendly with minimal tweaks required from you.

REGULATORY - COLORANTS & PIGMENTS


What are FDA listing requirements for colorants and pigments?
Color additives are required to be pre-approved by FDA and listed in the color additive regulations before they may be used in food, drugs, cosmetics, and medical devices. Each color additive is permitted only for the intended use stated in its listing regulation.
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