Specifications, scientifically valid methods, and laboratory data review under 21 CFR 111.110(c). Every Form 483 in your category cites at least one. WLTR provides the independent verification layer above your CDS — built to detect what manual review and CDS-native tools cannot.
WLTR is calibration data intelligence infrastructure for regulated laboratories. The platform sits above your existing chromatography data system — Empower, Chromeleon, OpenLab CDS, LabSolutions — and re-evaluates calibration mathematics against your own data. The CDS remains the system of record. WLTR verifies what the CDS produces.
FDA inspections of dietary supplement laboratories now turn on three repeated phrases: *specifications established* under 21 CFR 111.70 and 111.75, *scientifically valid methods* under 111.75(h)(1), and *review and approve the results of required tests* — including the electronic audit trail — under 111.110(c). Each phrase corresponds to a specific Part 111 citation. Each is currently being issued at the highest volume on record.
Certified Laboratories analysis, FDA Inspection Observations Database, 2025
cGMP Consulting analysis of FDA inspection data, 2025
Regulatory Affairs Professionals Society reporting on remarks by Jill Furman, Director of CDER's Office of Compliance, December 2025
FDA issued a public Warning Letter citing adulterated dietary supplement violations including current Good Manufacturing Practice failures under 21 CFR Part 111. The action established the firm’s products as adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act, with public reputational and commercial consequences (Cohen Healthcare Law Group analysis, 2025).
CDER issued a Warning Letter classifying the firm’s dietary supplement as an unapproved drug under the Federal Food, Drug, and Cosmetic Act because product claims drifted into disease treatment territory. The action illustrates the second enforcement vector active in this vertical — claim-based reclassification — alongside the cGMP enforcement path (Cohen Healthcare Law Group analysis, 2025).
WLTR connects to existing CDS installations. Methods do not change. CDS records remain the system of record. WLTR adds the independent verification layer 21 CFR Part 111 inspectors expect to see documented.
WLTR validates calibration mathematics. The platform re-evaluates the mathematical fit of every calibration model in your CDS against your own data and identifies models that pass routine acceptance criteria but contain undetected error in the dose-response range that determines compliance. Validation occurs across HPLC, UHPLC, LC-MS, and GC-FID assays for vitamins, polyphenols, amino acids, fatty acids, and botanical markers.
WLTR verifies specification conformance. The platform evaluates whether calibration outputs support the component and finished-product specifications required under 21 CFR 111.70(b) and 111.75 — identity, purity, strength, composition, and contamination limits — and serves as the independent verification mechanism that 21 CFR 111.75(h)(1) “scientifically valid method” review demands.
WLTR documents calibration evaluation in regulator-aligned language. The platform produces records aligned with FDA enforcement vocabulary: scientifically valid method justification under 111.75(h)(1), Quality Control review documentation under 111.110(c), and electronic audit-trail evidence aligned with 21 CFR Part 11 — reducing the audit-defense burden at the moment of inspection.
At ISO/IEC 17025-accredited contract testing organizations and brand-owner in-house QC laboratories. The role balances throughput, instrument fleet management, and the cost of maintaining 21 CFR Part 11-compliant CDS environments while preserving accreditation continuity and customer audit defensibility. WLTR adds verification documentation without adding instruments, headcount, or method changes.
Owns specifications, SOPs, and the quality system. Carries direct responsibility under 21 CFR 111.110 for review and approval of test results — including the electronic audit trail. The career-risk event is a Form 483 citing 111.70 specifications or 111.75(h)(1) method validity. These were the most-cited observation categories in dietary supplement inspections in both 2023 and 2024.
Operates the HPLC, UHPLC, LC-MS, GC-FID, and ICP-MS instruments. Builds and reviews calibrations analyte-by-analyte across botanical extracts, vitamins, minerals, amino acids, and contaminant panels. Carries the daily burden of identity testing under 21 CFR 111.75(a)(1)(i) and method appropriateness verification under 111.320. WLTR supports the analyst in calibration evaluation without changing the bench workflow.
WLTR verifies what the CDS produces — it does not redefine specifications under 21 CFR 111.70, alter the methods required under 21 CFR 111.320, or replace compliance-critical results.
Bring a calibration. We will run WLTR against it and document what the platform identifies.
