COSMETICS MoCRA INSPECTION RESPONSE RECORD · AUTHORIZATION RECONSTRUCTION

Under MoCRA, the investigator asks how the Responsible Person decided. This is the record that answers them.

Your quality system documents what was tested, approved, and released. It rarely preserves how the Responsible Person determined the product was safe and compliant for distribution — the evidence reviewed, the risks weighed, the alternatives rejected, and why the decision was justified at that moment. That reasoning is what an FDA investigator reconstructs under MoCRA.

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This record is generated from your structured inputs only. ComplianceWorxs does not invent evidence, fabricate safety conclusions, determine compliance, or substitute generic language for reasoning. Gaps are flagged. Authorization belongs to the named Responsible Person — not the platform. Your inputs are encrypted in transit and at rest, stored under access controls, and used only to generate your authorization record. ComplianceWorxs does not have access to your facility data or quality systems.

Step 1 of 6 Decision Identity

RECORD — IN PREPARATION

One cosmetic decision. One inspection-grade authorization record. ~12–18 minutes. Want to see the finished package first? See a full sample →

MoCRA INSPECTION RESPONSE RECORD — COSMETICS One authorization moment, reconstructed to inspection grade. Select the decision under inspection in Step 1.

Step 1 of 6 · Decision Identity

Identify the decision under inspection.

The decision class, and the identifiers an investigator will use to locate it. ~90 seconds.

Decision domain

Record / reference ID Product / brand in scope

Facility / company name FDA facility registration number

Responsible Person (name) Responsible Person title

Step 2 of 6 · Regulatory Question & Authorization Summary

What is the regulatory question, and what did the Responsible Person authorize?

The exact MoCRA-facing question this record answers, and the executive summary of the authorization. ~3 minutes.

The regulatory question The decision authorized Authorizing Responsible Person, business & regulatory context Why authorization occurred at that moment

Step 3 of 6 · Evidence Reviewed

What evidence did the Responsible Person review?

Product evidence (specs, formulation, stability, micro, PET), safety evidence (toxicology, supplier data, literature, historical safe use), and operational evidence (deviations, complaints, adverse events, investigations). Classify each by weight. No vague references.

Evidence streams (name each one specifically)

Primary evidence directly establishes the basis for the decision. Supporting evidence reinforces it. Corroborating evidence is consistent but not load-bearing.

Step 4 of 6 · Risk Evaluation

How was risk evaluated, and why was residual risk acceptable?

Consumer safety, product quality, labeling, regulatory, and business risk — with hazards, severity, probability, exposure, and the basis on which residual risk was accepted. ~4 minutes.

Consumer safety risk — hazards, severity, probability, exposure Product quality, labeling & regulatory risk Business / operational exposure Residual risk & why it remained acceptable

Step 5 of 6 · Alternatives & Authorization Rationale

What else could have been decided — and why was this justified?

Investigators reconstruct the paths not taken. Show you considered them first. Then the core reasoning: how the evidence was weighed into a justified authorization. ~5 minutes.

Alternatives considered & rejected (mandatory)

Each alternative action, risk response, or disposition that existed, and the specific basis on which it was rejected.

Why the authorized path was selected Authorization rationale — the core reasoning

PREVIEW — GENERATED RECORD

Regulatory question

Authorization summary (preview)

0Gaps flagged

5Deliverables

MoCRADecision domain

UNLOCK — DISCLOSURE

What unlocks

The complete Inspection Defense Package — five deliverables generated from this one decision: Executive Brief (decision, basis, exposure, required action), Defensibility Analysis (the inspection-readiness rating and the exposures that put it at risk), Response Kit (paste-ready language to close each gap), Investigator Challenge Guide (the questions an investigator is likely to ask, with answers to rehearse), and the full Authorization Record across all ten sections.

Artifact format

An on-screen package you can save or print to a single QMS-uploadable PDF. Filename IRR-{REFERENCE-ID}-{YYYYMMDD}.pdf. Record ID, Responsible Person, registration number, and MoCRA anchors embedded as PDF metadata.

What is preserved

Your structured inputs verbatim. Evidence streams marked primary, supporting, or corroborating. Alternatives considered and the basis for rejecting each. Risk evaluation and acceptance rationale. Residual exposure and forward controls as stated. Gaps flagged by the system are surfaced — not hidden.

What ComplianceWorxs does not do

Does not invent evidence. Does not fabricate safety conclusions. Does not determine compliance. Does not substitute generic language for your reasoning. Does not assert authorization on your behalf.

Authorization responsibility

The named Responsible Person on this record — the Responsible Person listed in Step 1 — is the authorizing party. ComplianceWorxs is the recording medium, not the authorizer. Accountability and inspection defense remain with the named individual.

Payment unlocks the package. It reflects what you entered. Nothing more, nothing less.

Product testing does not explain authorization. The investigator reconstructs how the Responsible Person justified the decision.

$497 · per record · Designed for Responsible Persons, Quality & Regulatory Directors, and cosmetic brand owners