---

At FDAInspections.com, we specialize in helping cosmetic brands, contract manufacturers (CMOs), and distributors navigate the unique regulatory challenges associated with FDA inspections and cosmetic product compliance. Whether you are preparing for a routine FDA inspection, addressing FDA-483 observations and a Warning Letter, or launching a new product, we provide the expertise you need to succeed in a competitive and highly regulated industry.

Our mission: Protect cosmetic companies by ensuring full compliance with FDA regulations, reducing inspection risks, and building strong, defensible quality systems.

Why FDA Inspections of Cosmetics Matter

While cosmetics are not subject to pre-market FDA approval (except for color additives), they are still heavily regulated under:

• Federal Food, Drug, and Cosmetic Act (FDCA)

• Fair Packaging and Labeling Act (FPLA)

• Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

Failure to comply can result in:

• FDA Warning Letters

• Import Alerts and Product Seizures

• Classifications of products as unapproved drugs

• Brand damage and regulatory enforcement actions

🔗 Learn About Cosmetic Regulations (FDA.gov)

How FDA Inspections .com Helps Cosmetic Companies

1. FDA Inspection Readiness Audits for Cosmetics

We perform comprehensive mock inspections tailored to cosmetic manufacturing and marketing operations.

• GMP audits adapted for cosmetic operations

• Labeling reviews for ingredient declarations and claims

• Risk assessments for contamination control and facility sanitation

Schedule a Cosmetic Compliance Audit

2. Warning Letter and Enforcement Action Assistance

If your company receives an FDA Warning Letter or Import Alert, we offer urgent and effective remediation services to your FDA Warning Letters and FDA-483 observations. .

• Root cause analysis and CAPA planning

• Response drafting and documentation support

• Recall strategies and adverse event reporting system development

Get Help With Your FDA Warning Letter

3. Label and Claims Compliance

Cosmetic labeling must meet strict FDA and FTC requirements. We assist with:

• Ingredient statement and INCI name compliance

• Prohibited and restricted ingredients review

• Structure/function vs. drug claim differentiation

• Labeling reviews under the new MoCRA requirements

Review Your Cosmetic Labels and Claims

4. MoCRA Compliance Support

The Modernization of Cosmetics Regulation Act (MoCRA) introduced new FDA registration, adverse event reporting, and GMP expectations.

• Facility registration and product listing assistance

• Adverse event recordkeeping system setup

• GMP program development for cosmetics

Learn About MoCRA Compliance Support

Common FDA Focus Areas During Cosmetic Inspections

• Ingredient safety and documentation

• Facility sanitation and contamination prevention

• Proper labeling and avoidance of drug claims

• Adverse event reporting procedures

• Recordkeeping for product formulations and complaints

Types of Cosmetic Products We Support

At FDA Inspections .com, we work with companies across a wide range of cosmetic categories, each requiring specialized compliance support.

Skincare Products

• Moisturizers, cleansers, serums, facial masks

Support includes:

• Ingredient safety verification

• Labeling compliance and claims review

Haircare Products

• Shampoos, conditioners, styling products, hair dyes

Support includes:

• Color additive compliance checks

• Marketing claims substantiation (e.g., “strengthens hair”)

Color Cosmetics

• Foundations, lipsticks, eyeliners, blushes

Support includes:

• Proper color additive usage and certification

• Labeling review for shade names and ingredient disclosures

Fragrances and Perfumes

• Eau de parfums, eau de toilettes, body sprays

Support includes:

• Ingredient listing compliance

• Allergen disclosure guidance

Personal Care Products

• Deodorants, lotions, sunscreens (if cosmetic SPF claims only)

Support includes:

• Differentiating cosmetic vs. OTC drug classification

• Ingredient and labeling compliance

Frequently Asked Questions About FDA Cosmetic Inspections

Q: Are cosmetics subject to FDA approval before marketing?
A: No, cosmetics do not require FDA pre-approval. However, companies are responsible for ensuring product safety and regulatory compliance.

Q: What is the biggest FDA risk for cosmetic companies?
A: Improper marketing claims that make a cosmetic appear to be an unapproved drug (e.g., “heals eczema,” “cures wrinkles”) and contaminated products.

Q: How often does the FDA inspect cosmetic facilities?
A: Inspections are typically risk-based, driven by complaints, adverse events, or regulatory priorities.

Q: Can FDAInspections.com assist international cosmetic brands entering the U.S. market?
A: Absolutely. We help both domestic and international cosmetic companies comply with FDA regulations and prepare for inspections.