The ever-changing regulatory requirements have created one of the biggest challenges to the food, dietary supplement, functional food, and cosmetics and personal care industries. We specialize in one-stop regulatory compliance services that include:
cGMPs - Food, Dietary Supplement, Cosmetics and Personal Care
cGMP stands for current Good Manufacturing Practices, which are regulatory standards established by FDA for a business manufacturing, processing, packaging, labeling, and holding of regulated products such as human and animal foods, dietary supplements, drugs, and medical devices while "current" refers updating technology, interpretation, and enforcement in GMP. CPC has successfully helped many manufacturers, co-packers, distributors, and brand owners in all sizes to develop and implement cGMP systems, obtain third-party GMP certifications, and pass FDA inspections. Learn more...Contact Us
FDA 483s and Warning letters
FDA uses Form 483 to document and communicate inspectional observations discovered during facility inspections. A recipient of a 483 should respond to the FDA within 15 business days regardless of the number of observations. Failure to timely and adequately address observations listed in the 483 forms would lead to FDA issuing a warning letter for violations of regulatory significance to the facility. While a response to a 483 is not compulsory, a response to a warning letter is. Ignoring FDA warning letters will result in serious consequences such as product confiscation, recalls, court injunctions including but not limited to jail time, ban from business operation, and etc.
Companies should treat FDA 483s and/or warning letters seriously and prevent escalation from a 483 to a warning letter. CPC's experts have years of experience successfully helping clients resolve 483s and warning letters directly with the FDA. CPC will help you develop and implement corrective actions, create comprehensive, well-documented and timely responses addressing each item on the 483s and warning letter, indicating agreement and providing a timeline for correction that can not be implemented immediately and requesting clarification of FDA's expectations. Learn more, Contact Us
FDA Inspection Onsite Support
Each year the FDA conducts numerous domestic and foreign facility inspections, which is a powerful surveillance tool that FDA increasingly uses to verify whether food establishments comply with relevant regulations. While dealing with an FDA inspection could be intense and intimidating, our experts can help you prepare for and navigate the inspection process, interpret FDA findings and provide timely solutions to observations to minimize 483s, limit errors associated with inspections, and provide confidence and knowhow of handling challenging issues that lead to a fair outcome of inspections. In addition, we will help you respond to 483s if any. Learn more, Contact Us
Whether you are a manufacturer, customer, importer, or a third party certification organization, our experienced auditors can conduct audits domestically and internationally in food, dietary supplement, cosmetics, laboratory, OTC, CRO, and medical device facilities on behalf of you. We update our audit checklists regularly to reflect the current thinking of regulatory agencies as well as customer requirements, timely deliver in-depth audit reports, and provide consulting services to ensure you meet regulatory standards and customer requirements upon requests. Our audit services include:
Onsite and Remote Audits
GMPs, FSMA, FSVP, GLP, and GCP Audits
Mocked FDA Audits
Contracted 3rd Party Audit
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Generally Recognized as Safe (GRAS) and New Dietary Ingredient Notification (NDIN)
Before you commercialize a novel ingredient used in food and or dietary supplement product, you are required by FDA to ensure that the ingredient is safe for intended use through GRAS Self-Affirmation, GRAS notification, and NDIN processes. Our product safety experts can help you determine which process is better suited for your business based on the ingredient identify, properties, scientific and safety data, historical use, and intended use.
To learn more about our GRAS/NDIN Assessment, GRAS Self-Affirmation, GRAS Notification, and NDIN services, Contact Us
Label Review - Food, Dietary Supplement, and Cosmetics
Before you place a product of food, dietary supplement, and cosmetic into interstate commerce or import it into the United States, you are required to comply with labeling regulations. FDA will declare a product "Misbranded" if the label fails to meet labeling laws, which will lead to further FDA enforcement actions such as import detention, import refusal, import alert, 483s, warning letters, and etc. The FTC also has jurisdiction authority over product claims of product labeling.
Mandatory information and voluntary information are the two essential elements of a product label. Mandatory information includes product name, statement of identity, quantity, nutrition/supplement fact panel, ingredient list, manufacturer/distribution contact information, allergen statement, and etc, while voluntary information includes product claims, artwork, and other promotional and informative messages. The regulatory definition of "labeling” includes “all labels and other written, printed, or graphic matters (1) upon any article or any of its containers or wrappers, or (2) accompanying such an article.” This may include packaging, instructions, product inserts, websites, and other promotional materials".
Our experts provide fast and effective label review services to ensure that the mandatory content and format, as well as product claims and other marketing messages, comply with FDA and FTC requirements. Our label review services include:
Verify and advise of mandatory label information
Evaluate and advise product claims (Nutrient Content Claims, Structure/Functional Claims, and Health Claims)
Evaluate and advise other marketing and promotional messages
Substantiate product claims
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Our trainers are experts in the subjects they teach, with years of experience providing professional training to help your employees understand and comply with current regulatory requirements and customer standards. Our training services include:
In-person and online training
FSMA training (PQCI, FSVP, Intentional Adulteration, and FSMA rules)
GMP training (Food, Dietary Supplement, Cosmetics)
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