An independent verification layer above your CDS. Built for cosmetics laboratories now operating under MoCRA, FDA inspection, and state ingredient-ban enforcement.
The boundary is structural. WLTR does not modify your analytical method. WLTR does not redefine acceptance criteria. WLTR does not generate or replace the reportable result. The CDS does. WLTR verifies what the CDS produces.
The Modernization of Cosmetics Regulation Act of 2022 brought facility registration, mandatory product listing, serious adverse event reporting, safety substantiation, mandatory recall authority, and forthcoming Good Manufacturing Practice rulemaking to a category that operated under largely voluntary federal oversight for eighty-four years. Cosmetics laboratories now produce documentation under regulatory scrutiny they have not historically faced.
FDA Summary Data on Registration and Listing of Cosmetic Product Facilities and Products, March 13, 2025; figures current as of January 1, 2025.
Reed Smith analysis of FDA Compliance Dashboard, December 30, 2025.
FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, launched September 12, 2025.
The vocabulary of recent enforcement reads consistently across the warning letters: *data integrity, scientifically sound specifications, validated test methods, laboratory controls, supplier reliability.* These are not abstract concerns. They are the regulatory phrases under which actions are now being issued.
Action : Following a July 2024 inspection, FDA cited the firm under 21 CFR 211.100(a) for inadequate process validation, 21 CFR 211.84(d) for failure to test components and validate supplier certificates of analysis, 21 CFR 211.160(b) for failure to establish scientifically sound and appropriate specifications, standards, sampling plans, and test procedures, and 21 CFR 211.22(a) for inadequate quality unit oversight.
Action : Following an October 2025 inspection, FDA cited the firm under 21 CFR 211.165(b) for failure to conduct microbiological batch testing, 21 CFR 211.84(d) for failure to test components and validate supplier analyses, and 21 CFR 211.22 for inadequate quality unit oversight. The letter additionally documented that the firm relied on artificial-intelligence agents to draft drug product specifications, procedures, and master production records, and characterized that reliance as a CGMP violation under 21 CFR 211.22(c).
You make capital decisions on instrument fleet and balance return on investment against compliance cost. You are now responsible for translating the ISO 22716 laboratory-controls section and the forthcoming MoCRA GMP rule into operational reality — a domain most cosmetics organizations have not historically built out. WLTR is the layer that makes that buildout defensible without rebuilding the CDS.
You own the quality system, write the SOPs, manage the fifteen-business-day adverse event clock under MoCRA, and maintain safety substantiation records under section 606. You defend data integrity in inspections that the cosmetics industry has not historically faced at this frequency. WLTR documents what your CDS does not surface, in language an inspector recognizes.
You operate the HPLC, UHPLC, GC, GC-MS, and LC-MS/MS that produce the laboratory’s daily output. You build calibration curves across complex emulsion, anhydrous, and color-cosmetic matrices, and you carry the trace-level quantification work at 0.001 percent thresholds where calibration quality directly determines pass-fail. WLTR re-evaluates the mathematics behind the curves you build.
You are the manufacturer, packer, or distributor whose name appears on the product label. You are the legally accountable party under MoCRA. Facility-registration suspension under section 607(b) prevents distribution. Mandatory recall authority is now codified. WLTR produces the documentation that protects your registration before an inspector requests it.
Per 21 CFR 211.160(b), laboratory controls “shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.” WLTR makes that requirement verifiable. The method does not change. The acceptance criteria do not change. The reportable result is generated by the CDS.
Walk through your laboratory’s calibration data with the WLTR team. See what your CDS does not surface.
