Manufacturing

CitriSafe products are manufactured in partnership with Western Innovations Inc., an SQF-certified, cGMP-compliant dietary supplement facility in Denver, Colorado.

Western Innovations has operated as a contract manufacturing and co-packaging facility for nearly three decades, specializing in dietary supplements, food products, and botanical formulations. Their facility maintains comprehensive food safety and quality management systems that meet or exceed FDA requirements for dietary supplement manufacturing.

As a contract manufacturing partner, Western Innovations produces CitriSafe formulations according to specifications set and approved by CitriSafe, under CitriSafe’s direct quality oversight, and in compliance with all applicable regulatory standards.

CitriSafe and its manufacturing partners maintain independently verified certifications that are publicly verifiable and subject to regular renewal and re-audit:

SQF Food Safety Certification

Certificate #24095 | Rating: 91 (Good) | Edition 9 | Certified February 17, 2025

SQF (Safe Quality Food) is benchmarked by the Global Food Safety Initiative (GFSI), the international standard recognized by major retailers and regulatory bodies worldwide for food and supplement safety management systems. The SQF audit covers all aspects of facility operations including:

• Management commitment and food safety culture
• Hazard analysis and risk-based preventive controls
• Supplier approval and raw material control
• Personnel training and hygiene
• Facility and equipment maintenance
• Product identification and traceability
• Corrective and preventive action procedures

SQF Certificate #24095 is publicly searchable in the SQF database.

Current Good Manufacturing Practices (cGMP)

FDA 21 CFR Part 111 | Third-Party Verified

Our manufacturing facility operates in full compliance with FDA 21 CFR Part 111 — the federal regulations governing current Good Manufacturing Practices for dietary supplements. These regulations establish requirements for:

• Quality control procedures
• Manufacturing operations
• Laboratory operations
• Holding and distribution
• Records and recordkeeping
• Returned products and product complaints

cGMP compliance is independently verified through third-party evaluation as part of our ongoing quality assurance program.

HACCP Program

Hazard Analysis and Critical Control Points | Western Innovations Inc.

Western Innovations maintains a comprehensive HACCP program covering all stages of dietary supplement production. The HACCP Food Safety Team includes:

• Food Safety Officer (Coordinator)
• Chief Operating Officer
• Chief Executive Officer
• Production and warehouse personnel

The program identifies critical control points throughout the manufacturing process, establishes monitoring procedures, and documents corrective actions. Key control points include:

• Metal detection at final packaging
• Glass vial inspection for all glass-packaged products
• Temperature and environmental monitoring
• Foreign matter contamination prevention

ISO 17025 Accredited Laboratory Testing

Mérieux NutriSciences | International Laboratory Accreditation

All third-party testing is conducted by Mérieux NutriSciences (formerly Silliker Inc.), operating under ISO 17025 accreditation — the international standard for testing and calibration laboratory competence recognized by over 100 countries through the International Laboratory Accreditation Cooperation (ILAC).

CitriSafe requires independent laboratory verification of every product batch before release. No product is released for sale until all third-party test results are received and verified.

Testing Laboratory

All testing is performed by Mérieux NutriSciences (formerly Silliker Inc.), an ISO 17025–accredited laboratory network with facilities across North America. Mérieux NutriSciences is one of the world’s largest food and supplement testing laboratories, providing analytical services to the food, pharmaceutical, and dietary supplement industries.

Test Panels

Each production batch is tested against the following panels:

Heavy Metals Screening

• Arsenic
• Cadmium
• Lead
• Mercury

All heavy metals are tested to confirm levels below established safety thresholds per USP/NF standards.

Microbial Analysis

• Total Microbial Count
• Yeast
• Mold
• E. coli
• Salmonella
• Staphylococci
• Enterobacterial Count

Allergen Testing

• Gliadin (gluten) via R-Biopharm R5 ELISA method — confirmed <2.5 ppm (gluten-free)

Identity & Potency

• Active ingredient verification per USP/NF pharmacopeial standards
• Raw material identity testing
• Finished product potency confirmation

Certificates of Analysis

Certificates of Analysis (COAs) are generated for each production lot, documenting all test results, specifications, and compliance status. COAs are maintained in our quality records system and are available upon request for verification purposes.

Why Italy and Switzerland

When we say our ingredients are sourced from Italy and Switzerland, we’re not making a claim about terroir or tradition. We’re describing a specific pharmaceutical-grade manufacturing infrastructure that meets the highest global standards for ingredient purity, safety, and regulatory compliance.

S-Acetyl-Glutathione: Gnosis by Lesaffre

Our S-acetyl-glutathione is supplied by Gnosis by Lesaffre, a global leader in pharmaceutical-grade nutritional ingredients. Gnosis operates production facilities in both Italy and Switzerland under rigorous regulatory oversight:

Swiss Facilities Gnosis has maintained Swissmedic-authorized Active Pharmaceutical Ingredient (API) production since 2005. Swissmedic is Switzerland’s national authority for therapeutic products, with regulatory standards equivalent to the FDA and EMA.

Italian Facilities The Gnosis production site in Pisticci, Italy holds ISO 45001 certification for occupational health and safety management systems, reflecting systematic quality control across all manufacturing operations.

FDA Oversight Gnosis facilities have undergone FDA inspection, providing an additional layer of regulatory verification recognized by U.S. authorities.

Patented Crystalline Form The S-acetyl-glutathione we use is produced in a patented crystalline form (US Patent 9,834,579 B2, assigned to Gnosis SpA) that enhances stability and bioavailability. This specific form has undergone formal safety evaluation, with results published in Food and Chemical Toxicology, a peer-reviewed journal focused on the safety assessment of food ingredients and chemicals.

Citrus Seed Extracts: Swiss Botanical Specialists

Our citrus seed extracts are sourced from Swiss manufacturers specializing in botanical ingredient production under pharmaceutical-grade conditions. These facilities operate under Switzerland’s rigorous quality standards, ensuring consistent potency, purity, and freedom from contaminants across every batch.

Every CitriSafe product carries a lot number that enables full traceability from raw ingredient receipt through manufacturing, testing, and distribution.

What Traceability Means

• Raw Materials: Each incoming ingredient shipment is assigned a receiving lot number and undergoes identity verification before acceptance
• Manufacturing: Production records link finished product lot numbers to all raw material lots used in that batch
• Testing: Certificates of Analysis are tied to specific production lots
• Distribution: Shipping records connect lot numbers to destination and delivery dates

Why It Matters

If a quality issue is ever identified through our internal monitoring, third-party testing, or customer feedback, lot traceability allows us to:

1. Identify exactly which products may be affected
2. Determine the root cause by tracing back through the supply chain
3. Take targeted corrective action without disrupting unaffected inventory
4. Communicate clearly with affected customers

Lot numbers appear on all CitriSafe product packaging. Customers with questions about a specific lot can contact us for verification.

While manufacturing, testing, and ingredient supply are conducted by qualified third-party partners, all quality decisions are governed internally by CitriSafe. CitriSafe maintains responsibility for setting product specifications, approving raw material suppliers, reviewing Certificates of Analysis, and authorizing final product release. No third-party certification or test result substitutes for internal review and approval. Final quality authority rests with CitriSafe’s CEO & President, JW Biava.

The certifications, testing protocols, and traceability systems described on this page are not marketing claims. They are documented, audited, and independently verifiable. We believe transparency is the foundation of trust, and trust is essential when you’re helping people recover from environmental illness.

These standards are subject to regular renewal and re-audit. CitriSafe is committed to maintaining current certification status across all manufacturing and testing operations.

This page documents CitriSafe’s manufacturing processes, quality testing, supply chain standards, and batch traceability systems. It does not address product formulation rationale, clinical evidence, or therapeutic efficacy claims.

• Gnosis by Lesaffre — Company Overview
• Gnosis by Lesaffre — Facilities & Certifications
• Swissmedic — Swiss Agency for Therapeutic Products
• SQF Institute — Certificate Database
• US Patent 9,834,579 B2 — Crystalline Forms of S-Acetyl Glutathione
• Food and Chemical Toxicology — Safety Assessment of S-Acetyl-Glutathione