Probiotic Testing for FDA compliance
Reliable probiotic testing designed for FDA compliance. ISO 17025 accredited methods with detailed reporting to meet your regulatory requirements.
ISO 17025 
نتائج خلال 48 ساعة 
ضمان 100% 
إجابة سريعة
Probiotic 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: Probiotic Products Fail to Meet Label Claims for CFU Count
A review of popular probiotic products found that over 40% failed to meet the advertised CFU count at expiration, highlighting the critical importance of independent potency and viability testing.
Achieving fda compliance requires accurate, accredited laboratory testing that regulatory bodies and marketplace platforms trust. Qalitex Laboratories provides probiotic testing tailored for fda compliance requirements. Probiotic products require specialized testing to validate that the claimed strains are present, viable, and at the labeled potency at both manufacture and throughout shelf life. Qalitex Laboratories provides ISO 17025 accredited probiotic testing using culture-based and molecular methods to deliver accurate, defensible results. Our ISO 17025 accredited methods and detailed COA reports are designed to streamline your fda compliance process.
How Probiotic 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.
Probiotic Enumeration
We perform total viable count (TVC) and species-specific enumeration for commonly used probiotic strains including Lactobacillus, Bifidobacterium, Streptococcus, and Saccharomyces. Results are reported in CFU/g or CFU per serving as required for label compliance.
Strain Identification
We use 16S rRNA sequencing and culture-based identification to confirm strain identity at the species level. Essential for brands making specific strain claims on labels (e.g., Lactobacillus acidophilus NCFM).
Probiotic Stability Testing
Probiotic viability decreases over time. Our stability studies test products at defined intervals to establish accurate expiration dating, ensuring your potency claim is valid at end of shelf life — as required by NPA, USP, and industry standards.
الاختبارات والأساليب الرئيسية
المعايير المعمول بها
القطاعات التي نخدمها
كيف يعمل
ثلاث خطوات بسيطة للحصول على نتائجك
أرسل عيناتك
أرسل العينات إلى مختبرنا في إيرفاين أو سان دييغو مع نموذج الطلب.
الاختبار والتحليل
يطبق علماؤنا المعتمدون بـ ISO 17025 مناهج الاختبار المعتمدة.
استلام CoA
احصل على شهادة تحليل موقعة خلال 48–72 ساعة.
الأسئلة الشائعة
الأسئلة الشائعة
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 are probiotic CFU counts measured?
Probiotic CFU (Colony-Forming Units) are measured through culture-based enumeration methods that count viable organisms. Qalitex performs total viable count and species-specific enumeration for Lactobacillus, Bifidobacterium, Streptococcus, and Saccharomyces strains.
خدمات الاختبار ذات الصلة
Microbiology Testing for Quality control
microbiology testing for quality control
Probiotic Testing Near Irvine & San Diego, CA — ISO 17025 Accredited Lab
probiotic testing near me
Amazon Compliance Testing for FDA compliance
amazon compliance testing for FDA compliance
Amazon Compliance Testing for Amazon listing approval
amazon compliance testing for Amazon listing approval
هل أنت مستعد للبدء؟
اطلب عرض سعر لـ probiotic testing for FDA compliance. يرد فريقنا خلال 24 ساعة.