Uncompromising Quality.
21 CFR Part 111 cGMP Standards.
A four-tier analytical verification framework protecting your brand against recall risks and active degradation. From 100% inbound raw material identification via FTIR and NIR spectroscopy to finished batch release backed by verified Certificates of Analysis (COA).
Core Regulatory Standards & Accreditations
Every product batch is held to strict federal benchmarks, eliminating brand liability and expediting Amazon, retail, and export clearance.
cGMP Certified Facility
Strict adherence to Current Good Manufacturing Practice in manufacturing, packaging, labeling, or holding operations for dietary supplements.
FDA Registered Facility
Active federal facility registration on file with the FDA, subject to federal inspections and compliance oversight.
ISO/IEC 17025 Analytical Testing
Internal analytical laboratory calibrated alongside ISO/IEC 17025 accredited third-party validation partners for unbiased lot certification.
Clean Label & NSF for Sport Compliance
Dedicated production runs designed to meet strict anti-doping criteria (WADA banned substances list) and allergen-free clean label certifications.
The 4-Stage QA/QC Verification Framework
A continuous quarantine-to-release testing system. Materials cannot advance to subsequent stages until the Quality Assurance Unit executes physical and electronic release signatures.
Raw Material Quarantine & Identity Verification
Mandatory Standard Operating Procedures (SOPs):
Every shipment dock arrival is sampled using stainless steel composite grain samplers under ISO 8 cleanroom sampling hoods. The material cannot be weighed into batch production until QA releases the ERP electronic hold.
100% match with vendor COA and MNL strict raw material specifications.
Lot immediately tagged RED, quarantined in physical isolation, and rejected back to vendor. Zero compromise.
No material or capsule blend can be weighed, transferred, or filled without QA ERP unlock signatures.
Laboratory Cleanrooms & Analytical Testing in Action
Witness our Carrollton, Texas analytical laboratory suites, environmental monitors, and certified release testing equipment.
HPLC Potency Assay & Chromatography
Quantifies botanical marker compounds and active vitamins against USP standards before batch release authorization.
ISO Class 7 Environmental Monitoring & Gowning
Strict cleanroom gowning and airlocks maintain Class 10,000 conditions, preventing particulate and microbial contamination during capsule filling.
Trace Heavy Metal Screening (ICP-MS)
Screens 100% of incoming raw materials and finished lots for lead, arsenic, cadmium, and mercury per California Prop 65.
Precision QA/QC Analytical Instrumentation
Equipped with pharmaceutical-grade chromatography, mass spectrometry, and dissolution testing systems for internal verification and rapid turnaround.
High-Performance Liquid Chromatography
Separates, identifies, and quantifies active compounds in raw materials and finished products, verifying that label claims match actual shelf concentrations.
Inductively Coupled Plasma Mass Spectrometry
Ionizes sample matrices at 10,000°K argon plasma to detect and screen toxic heavy metals far below federal warning thresholds.
Fourier-Transform Infrared Spectrophotometer
Generates molecular infrared absorption spectrum within minutes upon dock arrival. No batch enters formulation without FTIR identity clearance.
USP Automated Disintegration & Dissolution Tester
Simulates human stomach and intestinal conditions to guarantee that solid dosage forms break down and release bioactives within required physiological windows.
Microbiological Incubators & Rapid Enumeration Suite
Validates microbial cleanliness of finished dietary supplements to guarantee consumer safety before Certificate of Analysis (COA) generation.
Specimen Certificate of Analysis (COA) Breakdown
Every production batch leaves our facility accompanied by an individual, lot-specific COA. Examine the exact metrics, testing methodologies, and acceptance thresholds verified for commercial distribution.
CERTIFICATE OF ANALYSIS (COA)
| Test Parameter | Test Method | Target Specification | Observed Result | Disposition |
|---|---|---|---|---|
| Appearance & Form Physical / Organoleptic | Visual / Organoleptic | Size '00' Clear Vegetable (HPMC) Capsule containing off-white to beige powder | Conforms to Specification | Conforms |
| Average Fill Weight Physical / Organoleptic | USP <2091> | 650.0 mg ± 5.0% (617.5 mg – 682.5 mg) | 651.8 mg | Pass |
| Disintegration Time Physical / Organoleptic | USP <701> | NMT 20 Minutes in Deionized Water @ 37°C | 11 Minutes 24 Seconds | Pass |
| Vitamin D3 (Cholecalciferol) Active Potency Assay | HPLC / USP Monograph | ≥ 5,000 IU / capsule (125 mcg) (100% - 120% label claim) | 5,340 IU (106.8% of Claim) | Pass |
| Zinc (as Zinc Bisglycinate Chelate) Active Potency Assay | ICP-OES / AOAC 2011.14 | ≥ 30.0 mg / capsule (100% - 115% label claim) | 31.4 mg (104.7% of Claim) | Pass |
| Quercetin Phytosome (Active) Active Potency Assay | HPLC-UV @ 370 nm | ≥ 250.0 mg / capsule | 258.6 mg (103.4% of Claim) | Pass |
| Lead (Pb) Heavy Metal Contaminants (ICP-MS) | ICP-MS / USP <2232> | < 0.50 ppm (mcg/g) (Target < 0.10 ppm) | 0.024 ppm | Pass |
| Arsenic (Inorganic As) Heavy Metal Contaminants (ICP-MS) | ICP-MS / USP <2232> | < 1.50 ppm (mcg/g) | 0.042 ppm | Pass |
| Cadmium (Cd) Heavy Metal Contaminants (ICP-MS) | ICP-MS / USP <2232> | < 0.50 ppm (mcg/g) | 0.008 ppm | Pass |
| Mercury (Hg) Heavy Metal Contaminants (ICP-MS) | ICP-MS / USP <2232> | < 0.10 ppm (mcg/g) | < 0.002 ppm (Below LOQ) | Pass |
| Total Aerobic Plate Count (TPC) Microbiological Screen | USP <2021> / FDA BAM | < 10,000 CFU / gram | < 100 CFU / gram | Pass |
| Total Yeast & Mold Count (TYMC) Microbiological Screen | USP <2021> | < 1,000 CFU / gram | < 50 CFU / gram | Pass |
| Escherichia coli Microbiological Screen | USP <2022> | Negative / 10 grams | Absent / 10g | Pass |
| Salmonella spp. Microbiological Screen | USP <2022> | Negative / 25 grams | Absent / 25g | Pass |
| Staphylococcus aureus Microbiological Screen | USP <2022> | Negative / 10 grams | Absent / 10g | Pass |
This specimen confirms all analytical tests conformed to 21 CFR Part 111 specifications. No lot is released into commercial inventory without authorized sign-off from our Quality Unit.
Schedule a Facility Walkthrough or Virtual Quality Audit
We believe brand trust is earned on the cleanroom floor. We invite procurement directors, VP of Quality, and regulatory teams to tour our Carrollton, Texas facility or conduct a comprehensive virtual desk audit under mutual NDA.