Antimicrobial Testing for FDA compliance
Reliable antimicrobial testing designed for FDA compliance. ISO 17025 accredited methods with detailed reporting to meet your regulatory requirements.
ISO 17025 
Resultados en 48 h 
100 % garantía 
Respuesta rápida
Antimicrobial 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 Issues Guidance on Antimicrobial Efficacy Claims for Personal Care Products
New FDA guidance requires substantiation for antimicrobial and antibacterial efficacy claims in personal care products, requiring validated in vitro testing from accredited laboratories.
Achieving fda compliance requires accurate, accredited laboratory testing that regulatory bodies and marketplace platforms trust. Qalitex Laboratories provides antimicrobial testing tailored for fda compliance requirements. Antimicrobial testing evaluates a product's ability to inhibit or kill microbial organisms. Qalitex Laboratories provides validated antimicrobial activity tests for natural ingredient brands, cosmetic preservative systems, and supplement products making antimicrobial claims. Our ISO 17025 accredited methods and detailed COA reports are designed to streamline your fda compliance process.
How Antimicrobial 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.
Minimum Inhibitory Concentration (MIC)
MIC testing determines the lowest concentration of a substance that inhibits visible growth of a microorganism after overnight incubation. We test against a panel of standard organisms including S. aureus, E. coli, P. aeruginosa, and C. albicans.
Minimum Bactericidal Concentration (MBC)
The MBC is the lowest concentration that kills ≥99.9% of the initial inoculum. MBC data is required for products making bactericidal claims and for natural preservative systems in cosmetics.
Preservative Efficacy (Antimicrobial Effectiveness Testing)
Per USP <51> and ISO 11930, we perform challenge testing to evaluate whether a cosmetic or pharmaceutical preservative system maintains product safety throughout its shelf life and during consumer use.
Ensayos y métodos clave
Normas aplicables
Sectores que atendemos
Cómo funciona
Tres sencillos pasos hasta sus resultados
Envíe sus muestras
Envíe las muestras a nuestro laboratorio de Irvine o San Diego junto con su formulario de pedido.
Análisis y resultados
Nuestros científicos acreditados según ISO 17025 aplican métodos de ensayo validados.
Reciba su CoA
Obtenga un certificado de análisis firmado en 48–72 horas.
Preguntas frecuentes
Preguntas frecuentes
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 is MIC testing?
Minimum Inhibitory Concentration (MIC) testing determines the lowest concentration of a substance that inhibits visible growth of a microorganism after overnight incubation. Qalitex tests against standard organisms including S. aureus, E. coli, P. aeruginosa, and C. albicans.
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