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At FDAInspections.com, we specialize in helping dietary supplement manufacturers, brand owners, distributors, and contract manufacturers (CMOs) navigate the complexities of FDA inspections and cGMP compliance. Whether you are preparing for a routine FDA audit, launching a new product, or responding to a FDA-483 observation, we provide the expertise and actionable strategies you need to stay compliant and succeed in the competitive supplement marketplace.

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

Why FDA Inspections of Dietary Supplements Matter

Dietary supplements are regulated differently from conventional foods and pharmaceuticals but must comply with:

• 21 CFR Part 111 – Current Good Manufacturing Practice (cGMP) for Dietary Supplements

• 21 CFR Part 101 – Food Labeling Requirements

• FSMA (Food Safety Modernization Act) – Preventive Controls for Dietary Ingredients and Finished Products

Failure to meet these standards can result in:

• FDA Form 483 Observations

• Warning Letters

• Import Alerts

• Seizures or Injunctions

• Brand damage and loss of consumer trust

🔗 Learn About Dietary Supplement Regulations (FDA.gov)

How FDAInspections.com Helps Dietary Supplement Companies

1. FDA Inspection Readiness Audits for Supplements

We perform mock FDA inspections tailored to the dietary supplement industry to uncover gaps before the FDA finds them.

• Full cGMP compliance audits (21 CFR Part 111)

• SOP and documentation reviews

• Labeling audits for compliance with supplement labeling regulations

• Risk assessments of manufacturing, packaging, and labeling operations

Schedule an FDA Readiness Audit

2. FDA-483 Response and Warning Letter Assistance

Received a FDA-483 or Warning Letter? Time is critical. We help you:

• Analyze FDA observations

• Develop root cause analyses and CAPA plans

• Draft professional FDA-483 response letters

• Guide remediation and ongoing compliance efforts

Get Help With Your 483 Response

3. Label Compliance and Claims Substantiation

Supplement labeling and marketing must comply with FDA and FTC rules. We support:

• Supplement Facts Panel compliance

• Ingredient review for allowed dietary ingredients

• Structure/function claims review and substantiation

• Avoidance of prohibited disease claims

Learn More About Label Compliance Support

4. Supplier Qualification and FSMA Compliance

Under FSMA and Part 111, you are responsible for verifying the compliance of your suppliers.

• Supplier audit programs

• Ingredient supplier qualification

• Raw material and finished product testing strategies

• FSVP compliance for imported supplements

Strengthen Your Supply Chain Compliance

Common FDA Focus Areas During Dietary Supplement Inspections

• Master Manufacturing Records (MMRs) and Batch Production Records (BPRs)

• Incoming raw material testing (identity testing requirements)

• Finished product testing or reliance on certificate of analysis (COA) verification

• Quality control unit responsibilities and documentation

• Complaint handling and product returns

• Adverse Event Reporting compliance

Types of Dietary Supplements We Support

At FDA Inspections .com, we understand that not all dietary supplements are created equal. Different supplement categories face unique regulatory challenges, labeling requirements, and compliance risks. Here’s a closer look at the types of dietary supplements we help companies prepare for FDA inspections and audits.

Vitamin and Mineral Supplements

• Single-ingredient supplements (e.g., Vitamin C, Vitamin D3)

• Multivitamin formulas

• Iron, calcium, magnesium, and other essential mineral supplements

Support includes:

• Labeling compliance for % Daily Values

• Ingredient testing verification

• Stability studies for potency over shelf life

Herbal and Botanical Supplements

• Turmeric, ashwagandha, elderberry, ginseng, and other botanical extracts

• Traditional herbal blends and teas

• Ayurvedic and Chinese medicine products

Support includes:

• Identity testing of raw materials (required by FDA)

• Claims substantiation for botanical health claims

• Adulteration and contaminant testing programs

Protein and Sports Nutrition Products

• Whey, casein, soy, pea protein supplements

• Pre-workout formulas, creatine, BCAAs

• Recovery powders and endurance supplements

Support includes:

• Label claims review for serving sizes and ingredient listing

• Testing of active compounds (e.g., creatine content validation)

• Compliance with FDA guidelines for structure/function claims

Weight Management Supplements

• Appetite suppressants

• Thermogenic fat burners

• Metabolism support products

Support includes:

• Ingredient qualification (especially for stimulants and novel compounds)

• Label warning language and disclaimer compliance

• FTC-compliant marketing claim review

Cognitive Health and Nootropic Supplements

• Brain function and memory support supplements

• Adaptogens, nootropic blends, focus enhancers

Support includes:

• Identity testing of nootropic ingredients

• Labeling compliance and health claims substantiation

• Ensuring marketing avoids unapproved disease claims

Immune Support Supplements

• Vitamin C, zinc, elderberry, echinacea supplements

• Multi-ingredient immune blends

Support includes:

• Ingredient potency verification

• Complaint handling system evaluations for adverse events

• Regulatory support for surge product launches during health crises

Frequently Asked Questions About FDA Dietary Supplement Inspections

Q: What triggers an FDA inspection for dietary supplements?
A: Routine surveillance, facility registration under FSMA, consumer complaints, or adverse event reporting can all trigger inspections.

Q: What is the biggest FDA inspection issue for supplement companies?
A: Failure to properly verify the identity of dietary ingredients and incomplete batch production records are among the most common findings.

Q: Do you help small supplement brands and startups?
A: Yes! We work with startups, emerging brands, and established manufacturers. Our programs are scalable to match your company’s size and risk level.

Q: Can FDAInspections.com help with GMP training for our staff?
A: Absolutely. We offer customized GMP training programs tailored for supplement production, quality control, and packaging personnel.