Peakfinity Labs

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    Quality Assurance & Compliance

    Quality Standards & Testing

    Every product leaving our facility undergoes a rigorous 3-tier quality control process — from raw material verification through finished product release. Backed by 45+ years of GMP-certified manufacturing excellence.

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    Independently Verified

    Our Certifications & Compliance

    We maintain the highest level of regulatory compliance and quality certifications in the industry — independently audited and verified annually.

    NSF GMP Certified

    Independently audited Good Manufacturing Practice certification across all production lines. Annual re-certification ensures ongoing compliance.

    FDA Registered Facility

    Fully registered with the U.S. Food & Drug Administration for dietary supplement and cosmetic manufacturing operations.

    ISO 9001:2015 Certified

    International quality management system certification ensuring consistent processes, documentation, and continuous improvement.

    cGMP Compliant

    Current Good Manufacturing Practice compliance per 21 CFR Part 111 for dietary supplements, covering facility, equipment, and personnel standards.

    3-Tier Quality Control

    Our Testing Process — From Receiving to Release

    Every product goes through four distinct quality checkpoints before it's approved for shipment. Nothing leaves our facility without passing every test.

    1. Raw Material Receiving

    • Identity verification via HPTLC or HPLC
    • Certificate of Analysis (COA) review from suppliers
    • Heavy metals screening (lead, arsenic, cadmium, mercury)
    • Microbial load testing (TPC, yeast, mold, E. coli, Salmonella)
    • Pesticide residue and aflatoxin testing where applicable
    • Quarantine hold until all results pass specifications

    2. In-Process Quality Checks

    • Blend uniformity testing at multiple sampling points
    • Weight variation checks on every production run
    • Fill count and content verification
    • Capsule/tablet hardness and disintegration pre-checks
    • Moisture content monitoring
    • Equipment calibration verification before each batch

    3. Finished Product Testing

    • Full potency and active ingredient assay
    • Disintegration and dissolution testing (USP protocols)
    • Microbiological testing on finished goods
    • Label claim verification against COA
    • Allergen cross-contamination screening
    • Final batch COA generation and approval

    4. Stability & Shelf-Life

    • Accelerated stability testing (40°C/75% RH)
    • Real-time shelf-life validation per ICH guidelines
    • Packaging integrity and seal testing
    • Color, odor, and appearance evaluation over time
    • Expiration date assignment based on stability data
    Full Traceability

    Documentation & Traceability

    Complete audit trails from raw material to finished product. Every lot number, every test result, every decision — documented and retained.

    Batch Production Records

    Complete records for every production run including raw materials used, equipment logs, environmental conditions, and personnel involved.

    Certificate of Analysis (COA)

    Every finished product ships with a COA documenting identity, potency, purity, and safety test results against specifications.

    Full Supply Chain Traceability

    From raw material supplier to finished goods shipment — every ingredient and component is tracked with lot numbers and audit trails.

    Regulatory Compliance Files

    FDA registration documents, GMP audit reports, SOPs, deviation reports, and CAPA (corrective action) documentation maintained on-site.

    Always Improving

    Continuous Improvement Program

    Quality isn't a destination — it's a daily practice. Our CI program ensures we're always raising the bar.

    Internal Audits

    Regular self-audits of every production line, storage area, and lab protocol against SOPs and regulatory standards.

    Staff Training

    Ongoing GMP training, certification renewal, and competency assessments for all manufacturing and QC personnel.

    Third-Party Inspections

    Scheduled and surprise third-party facility inspections to validate our internal quality systems.

    KPI Tracking

    Batch pass rates, deviation frequency, CAPA closure times, and customer complaint metrics tracked monthly.

    Equipment Modernization

    Continuous investment in state-of-the-art manufacturing, testing, and packaging equipment.

    CAPA System

    Formal Corrective and Preventive Action program ensures every deviation drives systematic improvement.

    Our Quality Guarantee

    Every product manufactured at Peakfinity Labs comes with our quality guarantee. If any product fails to meet our quality standards or your agreed-upon specifications, we will remake or refund at no additional cost. No questions asked. Your brand's reputation is our reputation.

    100% Remake Guarantee
    COA With Every Batch
    Full Traceability
    45+ Years Experience

    Certifications & Compliance

    FDA Registered
    GMP Certified
    ISO Certified
    Secure Manufacturing

    Trusted by Industry Leaders

    45+
    Years in Business
    1000+
    Brands Served
    50+
    States Shipped
    1978
    Family Owned
    100% Quality Guaranteed
    Secure & Confidential
    Family Owned Since 1980
    U.S. Based Team

    Frequently Asked Questions

    Common questions about our quality standards and testing processes.

    What quality certifications does Peakfinity Labs hold?

    Peakfinity Labs holds NSF GMP certification, FDA facility registration, ISO 9001:2015 certification, and full cGMP compliance per 21 CFR Part 111. Our facility is independently audited annually to maintain these certifications.

    Do you provide a Certificate of Analysis (COA) with every order?

    Yes. Every batch we manufacture ships with a comprehensive COA documenting identity, potency, purity, and microbiological test results. COAs are generated by our in-house QC lab and verified by management before release.

    What testing do you perform on raw materials?

    All incoming raw materials undergo identity verification (HPTLC or HPLC), heavy metals screening (lead, arsenic, cadmium, mercury), microbial load testing, and pesticide/aflatoxin screening where applicable. Materials are held in quarantine until all results meet our specifications.

    Can I get third-party testing done on my products?

    Absolutely. We can arrange third-party laboratory testing through our network of accredited labs. Many brands request independent verification for additional credibility with retailers or for marketing claims.

    How do you handle product recalls or quality deviations?

    We maintain a formal CAPA (Corrective and Preventive Action) system. Any deviation triggers immediate investigation, root cause analysis, and corrective action. Our full traceability system allows us to isolate affected batches within hours, not days.

    What is your quality guarantee?

    Every product manufactured at Peakfinity Labs comes with our quality guarantee. If any product fails to meet agreed-upon specifications or our quality standards, we will remake or refund at no additional cost.

    Do you test for allergens and cross-contamination?

    Yes. We perform allergen cross-contamination screening and maintain strict equipment cleaning protocols between production runs. Our facility follows allergen control procedures aligned with FDA requirements.

    How long do you keep batch records and testing data?

    We retain all batch production records, COAs, raw material documentation, and testing data for a minimum of 3 years beyond the product's expiration date, per FDA regulatory requirements.

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