Chemical Testing for FDA compliance
Reliable chemical testing designed for FDA compliance. ISO 17025 accredited methods with detailed reporting to meet your regulatory requirements.
ISO 17025 
48 小时出结果 
100% 保证 
快速解答
Chemical 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.
Qalitex Raises Alarm on Undisclosed Allergens in Contract-Manufactured Products
Chemical analysis at Qalitex identified undeclared allergens (gluten, soy, dairy) in multiple contract-manufactured supplement products — a finding that would have triggered FDA action if released to market.
Achieving fda compliance requires accurate, accredited laboratory testing that regulatory bodies and marketplace platforms trust. Qalitex Laboratories provides chemical testing tailored for fda compliance requirements. Qalitex Laboratories offers a full suite of chemical testing and analysis services for dietary supplement, food, and cosmetic brands. Our ISO 17025 accredited laboratory uses state-of-the-art instrumentation including HPLC, ICP-MS, GC-MS, LC-MS/MS, FTIR, and UV-Vis spectroscopy to deliver accurate, validated results. Our ISO 17025 accredited methods and detailed COA reports are designed to streamline your fda compliance process.
How Chemical 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.
Our Chemical Testing Capabilities
We cover the full range of chemical analysis needs: identity and authentication, potency and quantification, impurity profiling, contaminant screening (heavy metals, pesticides, solvents), and physical-chemical properties (pH, viscosity, moisture, water activity).
Method Development & Validation
For novel ingredients or products without pharmacopeial monographs, we develop and validate custom test methods per ICH Q2(R1). This includes selectivity, linearity, range, accuracy, precision, and robustness studies, producing a validated method suitable for regulatory submission.
主要检测项目与方法
适用标准
服务行业
检测流程
三个简单步骤获取结果
提交样品
将样品连同订单表格寄送至我们的尔湾或圣地亚哥实验室。
检测与分析
我们的 ISO 17025 认证科学家使用经过验证的检测方法进行分析。
收取 CoA 报告
在 48–72 小时内获得签名的合格证书。
常见问题
常见问题解答
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.
What chemical testing capabilities does Qalitex have?
Qalitex provides identity and authentication, potency and quantification, impurity profiling, contaminant screening for heavy metals and pesticides, residual solvent testing, and physical-chemical property testing using HPLC, ICP-MS, GC-MS, LC-MS/MS, FTIR, and UV-Vis spectroscopy.
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