Common Questions
Quality & Compliance
Our production facility operates under strict quality management systems encompassing facility design, equipment calibration, personnel training, testing programs, documentation systems, and regulatory compliance. Every element of our operation is designed to ensure consistent product identity, purity, strength, and composition.
In Business
Since 2006
Veteran-Owned
Vegan
Product
GMP
Certified
GMO Free
Gluten Free
Made in USA
cGMP Certified Facility
Our manufacturing facility operates under current Good Manufacturing Practice (CGMP) standards. This certification verifies that our production processes, quality control systems, and facility conditions meet the requirements for dietary supplement manufacturing.
CGMP compliance ensures consistent product identity, purity, strength, and composition across every production batch.
Facility Design Controls
Purpose-built production environment with controlled temperature, humidity, and air filtration systems designed to prevent contamination and ensure product integrity.
Equipment Calibration Program
All production and testing equipment maintained on documented calibration schedules with traceable standards and deviation protocols.
Personnel Training & Qualification
Comprehensive training program covering CGMP requirements, SOPs, hygiene practices, and job-specific competencies with documented qualification records.
Process Validation Protocols
Critical manufacturing processes validated through IQ/OQ/PQ protocols to demonstrate consistent, reproducible results within established specifications.
Documentation & Record Systems
Complete documentation system covering SOPs, batch records, specifications, and change control with version management and periodic review.
Corrective Action (CAPA) Procedures
Systematic approach to identifying, investigating, and correcting quality issues with root cause analysis and preventive action tracking.
FDA Compliant Facility
Our facility is registered with the U.S. Food and Drug Administration and operates in compliance with FDA regulations for dietary supplement manufacturing, labeling, and distribution.
FDA compliance covers facility registration, product labeling requirements, adverse event reporting, and adherence to 21 CFR Part 111 manufacturing standards.
21 CFR Part 111 Adherence
Full compliance with FDA regulations governing the manufacturing, packaging, labeling, and holding of dietary supplements.
Facility Registration & Inspection
Active FDA facility registration maintained with inspection-ready status and complete documentation availability.
Adverse Event Reporting
Established procedures for monitoring, documenting, and reporting adverse events in compliance with FDA requirements. .
Labeling Compliance
All product labeling reviewed for compliance with FDA requirements including supplement facts panels, ingredient declarations, and required disclaimers.
Current Good Manufacturing Practices
Ongoing compliance monitoring ensures manufacturing operations consistently meet evolving FDA standards and guidance.
Regulatory Documentation
Systematic approach to identifying, investigating, and correcting quality issues with root cause analysis and preventive action tracking.
Documentation & Traceability
Complete traceability from raw material receipt through finished product distribution. Our documentation system ensures full accountability and supports rapid response in any recall scenario.
Batch Record System
Every production lot tracked through a unique identification system from raw material sourcing through final distribution with complete chain of custody documentation.
Recall Readiness Protocol
Documented recall procedures with mock recall exercises conducted regularly to verify the ability to rapidly identify, locate, and recover affected product.
Recall Readiness Protocol
Documented recall procedures with mock recall exercises conducted regularly to verify the ability to rapidly identify, locate, and recover affected product. .
Retention Sample Program
Representative samples from every production batch retained under controlled conditions for the duration of product shelf life plus one year.
All quality claims are verified and documented. Certification details available to qualified partners upon request.