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ISO 17025 Accredited

Heavy Metal Testing for FDA compliance

Reliable heavy metal testing designed for FDA compliance. ISO 17025 accredited methods with detailed reporting to meet your regulatory requirements.

ISO 17025 Accredited 48-Hour Turnaround Available 500+ Test Methods FDA-Compliant Reporting Dual Locations: Irvine & San Diego, CA
ISO 17025 Accredited ISO 17025
48-Hour Rapid Testing 48h Turnaround
Satisfaction Guaranteed 100% Satisfaction

Quick Answer

Heavy Metal Testing for FDA compliance ensures products meet the specific regulatory and quality standards required for market entry. ISO 17025 accredited laboratories like Qalitex provide validated testing methods, detailed COA reports, and expert guidance to support fda compliance processes efficiently.

FDA ALERT

FDA Warns of Elevated Lead Levels in Dietary Supplement Products

The FDA issued safety warnings after detecting elevated lead concentrations in multiple supplement brands sold online, underscoring the need for independent third-party heavy metal testing before launch.

Achieving fda compliance requires accurate, accredited laboratory testing that regulatory bodies and marketplace platforms trust. Qalitex Laboratories provides heavy metal testing tailored for fda compliance requirements. If you make or sell dietary supplements, food or cosmetics, a heavy metal test is usually one of the first lab reports a buyer, retailer or regulator asks for. Qalitex runs heavy metal testing by ICP-MS for dietary supplements, food products and cosmetic formulations, with experienced chemists and documented protocols, so you know what is in your product and whether it meets the limit that applies. Our ISO 17025 accredited methods and detailed COA reports are designed to streamline your fda compliance process.

How Heavy Metal Testing Supports FDA compliance

FDA compliance requires documented evidence of product safety and quality. Qalitex provides the specific testing and documentation needed to support your fda compliance process, including detailed COA reports, method validation documentation, and expert consultation on testing scope. Our ISO 17025 accreditation ensures your results are accepted by regulatory bodies and marketplace platforms.

How do you test a product for heavy metals?

You send a representative sample of the finished product or raw ingredient to an accredited laboratory. The lab prepares the sample so the metals are dissolved in solution, measures each metal by ICP-MS, checks the run against quality controls, and reports a result for every metal. You then compare the result with the limit that applies to your product and market. If you are not sure which panel or method fits your product, ask before you ship the sample.

Why heavy metal testing is critical

Heavy metals like arsenic, lead, cadmium and mercury are toxic even at low concentrations. They can contaminate ingredients through soil, water, processing equipment and packaging. Regulators set limits to prevent harm such as neurotoxicity, kidney damage, developmental delays and carcinogenicity, and a failed or missing test can stop a product from being sold.

Heavy metals in supplements, food and cosmetics

Botanical and mineral ingredients, plant-based powders and extracts, and products made on metal equipment are common places for metals to show up, which is why testing is routine for dietary supplements and their raw materials. The same four metals matter in food and in cosmetic formulations. Testing the raw material and the finished batch can show where a problem enters.

Key Tests & Methods

Lead (Pb)
Cadmium (Cd)
Arsenic (As), total & inorganic
Mercury (Hg)
Multi-element ICP-MS panel
Prop 65 compliance panel

Applicable Standards

USP <2232> Elemental ContaminantsICH Q3DCalifornia Prop 65FDA 21 CFR guidelinesEU Regulation 1881/2006

Industries We Serve

Dietary supplements
Herbal & botanical products
Cosmetics & personal care
Food & functional foods
Amazon FBA sellers

How It Works

Three simple steps to your results

01

Submit your samples

Ship samples to our Irvine or San Diego laboratory with your order form.

02

Testing & analysis

Our ISO 17025 accredited scientists run validated test methods.

03

Receive your CoA

Get a signed Certificate of Analysis within 48–72 hours.

FAQ

Frequently Asked Questions

What testing is required for fda compliance?

FDA compliance typically requires identity testing, purity analysis, potency verification, and contaminant screening. The exact panel depends on your product type and target market. Qalitex Labs can recommend the appropriate testing scope for your specific fda compliance needs.

How long does testing take for fda compliance?

Standard turnaround at Qalitex is 5–7 business days, with rush 48-hour service available for most test types. We recommend planning testing 2–3 weeks ahead of your fda compliance deadline to allow for any retesting if needed.

Is Qalitex Laboratories ISO 17025 accredited?

Yes. Qalitex Laboratories holds ISO/IEC 17025 accreditation, the international standard for testing and calibration laboratories. This ensures our methods, equipment, and quality systems meet the highest standards of accuracy and reliability.

What is your turnaround time?

Standard turnaround is 5–7 business days. Rush service with 48-hour turnaround is available for most test types. Contact us to discuss your timeline requirements.

What types of products do you test?

Qalitex tests dietary supplements (capsules, powders, gummies, liquids), cosmetics and personal care products, food and beverage items, botanical extracts, and raw materials. We serve brands, contract manufacturers, and Amazon FBA sellers.

How do I submit samples for testing?

Ship your samples to our Irvine or San Diego laboratory with a completed sample submission form. We provide prepaid shipping labels for qualifying orders. Results are delivered electronically via secure portal.

How do you test for heavy metals in a product?

Send a representative sample to an accredited laboratory. The lab prepares the sample so the metals are in solution, measures each metal by ICP-MS, checks the run against quality controls and reports a result for every metal, which you compare with the limit that applies to your product.

Ready to get started?

Request a quote for heavy metal testing for FDA compliance. Our team responds within 24 hours.

ISO 17025 Accredited48-Hour Rapid TestingSatisfaction Guaranteed