FDA Compliance Services for Cosmetic Export 

The cosmetics industry in the United States is an extremely lucrative one; however, it is also the most tracked. The same regulations that are followed by manufacturers and distributors of cosmetic products in order to target the manufacturing of goods that can be successfully exported to the United States are relevant to those who produce and sell cosmetic products in the country based on the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Modernization of Cosmetics Regulation Act (MoCRA).

We, Compliance Networks, are offering consultancy services to the cosmetic manufacturing and exporters in the whole world giving FDA solutions that are incomplete. With or without skincare, haircare, makeup, fragrances, and personal care products, our specialists will guarantee your product brand that it fulfills all the requirements of the FDA regarding a safe and compliant entry to the U.S. market.

Industry: The Importance of FDA Compliance to Cosmetic Exporters

With MoCRA in effect, the FDA has eased greatly, with respect to the drafting over cosmetic products. Failure to comply may lead to detention of products, market recalls or even import withholds – this may hurt your goodwill and even postpone your business.

FDA compliance ensures:

• U.S. distribution regulatory approval.
  
• Consumer satisfaction by assuring of safety.
  
• Less risk of delivery rejection and recall.
  
• Easier penetration into other international markets that adhere to U.S. standards.
  

Compliance Networks is the easiest way to know and apply all those requirements – ingredient safety requirements, product registration and labeling requirements, etc. – in order to export without worry or violate compliance.

FDA Services Provided to Cosmetic Export Clients

We have a comprehensive package of regulatory services to cater to the requirements of cosmetic manufacturers, importers, and distributors of their products and aiming at the U.S. market.

1. Cosmetic Facility Registration and U.S. Agent Services

According to the MoCRA, any manufacturers and packers of cosmetics in foreign countries are required to obtain registration of the facilities with FDA. All facilities should also appoint a U.S. Agent who could be used as the point of contact of inspection, notices, and inquiries.

The Compliance Networks are helpful with:

• FDA Direct System registration Facility.
  
• Annual renewals and updates.
  
• Nomination and hiring of a competent U.S. Agent.
  
• Monitoring and responding to FDA communication.
  

We make sure that your facility is operational, approved, and inspection-compliant at all times of the year.

2. Listing Product and Ingredients Submission

The product names must be registered with the FDA including all information regarding the product like name, category, product formulation and contact person among others.

Our experts manage:

• Submission of product listing associate with FDA.
  
• Health and safety ingredient data compliance.
  
• Listings of multi SKUs are maintained and renewed.
  
• Checking of product classes and intended purpose.
  

It is making the listing process smooth with all the formulas and claims being in line with that of FDA.

3. Substantiation of Safety and Inspection of Ingredients

FDA stipulations engage that all the cosmetic products and ingredients be harmless amidst labelled or commonplace circumstances of use. The keeping of safety substantiation records is the responsibility of the manufactures and exporters.

Compliance Networks assists you in the creation or check-up of:

• Toxicological, dermatological safety data.
  
• Certificates of ingredient safety.
  
• Pageant and preservative limit reviews.
  
• Adherence to limited or forbidden ingredient lists.
  

Your formulations are safe, well documented and completely compliant according to the U.S. market, by our scientific team.

4. Labeling & Claims Compliance

Among the most frequent reasons of import detention are the errors in labeling cosmetics. The FDA has tough labeling regulations concerning ingredients, net contents, name of manufacturer and warnings.

We check and certify your product labels in order to certify:

• A list of ingredients is written in styles of INCI names.
  
• Clauses and assertions are not deceitful.
  
• Multidimensional (English/metric) measurements are stated in an appropriate way.
  
• Boundaries Cosmetic vs. drug claims There is a separation between cosmetic and drug claims.
  
• The packaging would contain the concerned individual, as well as the country of origin.
  

Our team provides clarity, compliance, and readiness of your labels in the U.S. as it distributes without incurring the risk of breaching the misbranding statutes.

5. Reporting Adverse Events / Records

The manufactures and importers under MoCRA have to keep records of complaints being raised about their products, and submit severe adverse occurrences to the FDA subject to strict deadlines.

Compliance Networks has systems established to handle:

• Procedures of adverse event reporting.
  
• Workflows Complaint tracking and investigation.
  
• CAPA (Corrective and Preventive Action) Systems.
  
• Ready retention of documents and inspection.
  

We ensure that your company meets post-market activities in an efficient and accurate manner.

6. cGMP Alignment and Audit Preparation

Even though many regulative backgrounds of cosmetics do not attract altogether drugs GMPs, the FDA declared that it will compel obligatory Good Manufacturing Practices (GMP) that relate to cosmetics regarding MoCRA.

We also assist your company in preparing early on by harmonizing your quality system and abiding by the updated principles of GMP which include:

• Facility hygiene control and process control.
  
• Employees and prevention of contamination.
  
• Record keeping, batch, and traceability.
  
• Supplier management and audits within the company.
  

Our pre-auditing services will keep your activities up-to-date to adapt to future FDA audit risks.

7. Customs & Import Compliance Assistance

Delay at ports is witnessed due to absence of importing or mismatch of information as an exporter. Withagent import compliance services assist you in:

• Make correct entry records and Prior Notes.
  
• Check before delivery, FDA registration and listing.
  
• Fast pact Resolve Detention Notices and Import Alderts.
  
• Contact FDA and the customs people on behalf.
  

We help your products to sail through the border hassle free and avoid wasting a lot of money in border delays.

Why Choose Compliance Networks

• Cosmetic Industry Experts: Our area of specialization is the FDA specifications which relate to cosmetic manufacturers and exporters.
  
• End-to-End Service: Since registration, labeling, safety substantiation, and reporting reporting after market, etc., we handle the entire process of compliance.
  
• U.S. Market Expertise: We know the interplay between the FDA regulations and the customary and retail distribution requirements.
  
• Experience-based Advice: Each segment of the cosmetic industry basketball skincare haircare-makeup fragrances — has its own set of rules, and we tailor your plan to them.
  
• Continued Cooperation: This ensures that your brand does not fall behind since the rules governing MoCRA are constantly changing and we are there to assist you.
  

Your FDA Cosmetic Compliance Partner

The FDA cosmetic regulations might be a complicated process and this might be the case when it started or operates under the Morreale cosmetic regulations. By choosing Regulator partner Compliance Networks, you are assured of peace of mind at least that all your registration, labeling, and safety files do not come short of the FDA expectations.

It is our mission to make compliance much easier so that you can concentrate on doing what is most important to you — the development of your brand and expanding your market in the United States.

Call Compliance Networks now at the time needed to connect on the topic of FDA compliance and begin a process of smooth and compliant exportation of cosmetics.

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