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wright__a2

ANDERSON

@wright__a2

FDA Regulatory Compliance Specialist

Verenigd Koninkrijk
Engels, Spaans, Duits, Frans
Sommige informatie wordt in het Engels weergegeven.
Over mij
I’m Anderson, an FDA Regulatory Compliance Specialist helping brands successfully enter the U.S. market. I specialize in FDA OTC drug registration, cosmetic and supplement compliance, facility registration, and label review. With a strong understanding of FDA regulations, I help you avoid FDA rejection, compliance penalties, and marketplace suspension by ensuring your documentation and labels meet U.S. standards before submission. If you need clarity, compliance, and fast execution — I’m here to guide you step-by-step.... Lees meer

Skills

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wright__a2
ANDERSON
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Bedrijfsregistratie
I will fda registration, label compliance review, , fda product listing
Bedrijfsregistratie
I will handle fda otc listing ,regisration and compliance , mocra product listing

Portfolio

Werkervaring

Confidential

FDA Label Design Review – Supplement, Skincare & Snack Bars

Confidential • Freelance

Jan 2026 - Present4 mos

Overview: Led the redesign and compliance review of product labels for three categories — dietary supplements, skincare, and snack bars — to ensure full compliance with FDA regulations. The primary goal was to launch new products into the U.S. market while avoiding regulatory delays or potential recalls due to improper labeling. Challenges: Incorrect serving size formatting and missing %DV (Daily Value) values. Omitted ingredient listings and improper net quantity declarations. Unverified claims such as “gluten-free” and “organic”. Non-compliant allergen statements and typography issues impacting FDA readability standards. Solutions Provided: Reformatting Nutrition Panels: Adjusted serving sizes and included accurate %DV values in compliance with FDA 21 CFR regulations and 2016 Nutrition Facts guidelines. Ingredient List Updates: Added complete INCI (International Nomenclature of Cosmetic Ingredients) lists for cosmetics, ensuring accurate ingredient disclosures. Verification of Claims: Corrected allergen statements and cross-checked claims like "gluten-free" and "organic" against FDA and USDA standards. Typography and Layout Adjustments: Ensured design adhered to FDA’s readability requirements, improving consumer accessibility. Outcome: Successfully delivered FDA-compliant product labels that passed third-party reviews. This ensured a smooth product launch without the risk of warning letters or regulatory penalties, while also fostering consumer trust through transparent labeling practices.