Microbiology Testing for FDA compliance
Reliable microbiology testing designed for FDA compliance. ISO 17025 accredited methods with detailed reporting to meet your regulatory requirements.
ISO 17025 
Resultados em 48 h 
100 % garantia 
Resposta rápida
Microbiology 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 Recall: Microbial Contamination Found in Supplement Products
Multiple dietary supplement products were recalled after routine microbiology testing identified Salmonella and Staphylococcus contamination, reinforcing the importance of routine microbial screening.
Achieving fda compliance requires accurate, accredited laboratory testing that regulatory bodies and marketplace platforms trust. Qalitex Laboratories provides microbiology testing tailored for fda compliance requirements. Qalitex Laboratories specializes in microbiological testing services designed to verify product safety, extend shelf life, and support regulatory compliance. Our testing protocols follow USP <61> and <62>, AOAC guidelines, and FDA regulations, ensuring your products meet the strictest standards for microbial safety. Our ISO 17025 accredited methods and detailed COA reports are designed to streamline your fda compliance process.
How Microbiology 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.
Microbial Limit Testing
Our comprehensive microbial limit tests detect and quantify total aerobic microbial counts (TAMC), total yeast and mold counts (TYMC), and specific objectionable organisms including E. coli, Salmonella, Staphylococcus aureus, and Pseudomonas aeruginosa.
Pathogen Screening
Our pathogen screening covers Salmonella, Listeria monocytogenes, E. coli O157:H7, Clostridium, and other pathogens relevant to your product type. Early detection prevents product recalls and protects consumers.
Preservative Efficacy Testing (Challenge Testing)
Preservative efficacy testing (PET), also known as challenge testing, assesses how well a product's preservative system inhibits microbial growth over time. Vital for products with water content or susceptible to contamination during use. We follow USP <51>, ISO 11930, and industry best practices.
Ensaios e Métodos Principais
Normas Aplicáveis
Setores que Atendemos
Como Funciona
Três passos simples para os seus resultados
Envie as suas amostras
Envie amostras para o nosso laboratório de Irvine ou San Diego com o seu formulário de pedido.
Análise e resultados
Os nossos cientistas acreditados pela ISO 17025 aplicam métodos de ensaio validados.
Receba o seu CoA
Obtenha um Certificado de Análise assinado em 48–72 horas.
Perguntas Frequentes
Perguntas Frequentes
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 microbiology tests does Qalitex perform?
Qalitex performs total aerobic microbial count (TAMC), total yeast and mold count (TYMC), pathogen detection for E. coli, Salmonella, Listeria, Staphylococcus aureus, and Pseudomonas, as well as preservative efficacy testing (PET) per USP <51> and ISO 11930.
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