No Quality System to Speak Of
Batch records that are really just batch logs. No deviation process. No CAPA. Decades of operating without GMP means the entire quality infrastructure has to be built — and built correctly the first time.
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MoCRA readiness for cosmetics manufacturers.
MoCRA is the first major update to US cosmetics law since 1938 — facility registration, adverse event reporting, safety substantiation, and GMP are now the price of admission. Most of the industry has never operated under GMP. We close that gap before FDA does.
WHY NOW
The grace period is ending.
Cosmetics operated for decades with minimal federal manufacturing oversight. MoCRA changed that — and the companies building GMP systems now will be the ones still standing when enforcement tightens.
1938The last time US cosmetics law saw a major update — until MoCRA arrived in December 2022.
MoCRAFacility registration, product listing, adverse event reporting, and safety substantiation are now federal requirements.
GMPFDA's proposed good manufacturing practice rule for cosmetics will set the manufacturing standard the industry never had.
WHERE IT BREAKS
The four gaps MoCRA exposes.
An industry that never needed GMP now needs it. These are the gaps we find most.
Adverse Events Unprepared
Serious adverse event reporting is now mandatory, but most brands have no intake process, no evaluation criteria, and no idea what the reporting clock requires. The first serious complaint becomes a crisis.
Safety Substantiation Missing
MoCRA requires adequate substantiation of product safety — records that many brands simply do not have. "We've always made it this way" is not substantiation.
Manufacturing Controls Undocumented
Mixing, filling, and packaging run on tribal knowledge. No validated processes, no equipment qualification, no change control. When FDA asks how you know it works, there is no answer on file.
WHAT WE DO
Our method, mapped to cosmetics.
The same evidence discipline we built in cannabis — adapted to MoCRA and FDA's proposed cosmetics GMP. And when the assessment finds gaps, we don't just hand you a report — we execute the full validation work (IQ/OQ/PQ, process validation) to close them.
MoCRA Readiness Assessment
Our flagship four-week engagement, baselined against MoCRA requirements and FDA's proposed GMP: facility registration status, manufacturing controls, quality oversight, complaint and adverse-event handling, labeling, and records.
You receive a prioritized gap register ranked by risk — and a build sequence for the quality system the industry never had.
CQV for Cosmetics Plants
Commissioning and qualification for mixing, filling, and packaging lines — IQ/OQ/PQ scaled to the operation, plus utilities and controlled environments where they matter.
CSV for Quality & Batch Systems
Risk-based validation for batch-record, inventory, and complaint-tracking systems — requirements, testing, audit trails, and data integrity for the records FDA will read first.
Quality Systems, Built Right
SOP development, batch-record design, deviation and CAPA processes, adverse-event procedures, and safety-substantiation file structure — the full infrastructure, sequenced so the highest-risk gaps close first.
THE RULES THAT CREATE THE BURDEN
What you're actually being judged against.
MoCRA (2022)
Facility registration, product listing, adverse event reporting, safety substantiation, labeling — the new federal baseline for every cosmetics brand selling in the US.
Proposed Cosmetics GMP
FDA's proposed good manufacturing practice regulation will define the manufacturing standard — documentation, controls, and quality oversight the industry has never been held to.
Adverse Event Reporting
Serious adverse events must be reported to FDA on a defined timeline. Intake, evaluation, and recordkeeping procedures are now mandatory infrastructure.
Labeling Requirements
Ingredient declaration, warning statements, and the evolving fragrance-allergen disclosure landscape — labels are enforcement's lowest-hanging fruit.
QUESTIONS
Cosmetics, answered.
What does MoCRA actually require from cosmetics manufacturers?
The Modernization of Cosmetics Regulation Act — the first major update to US cosmetics law since 1938 — requires facility registration, product listing, serious adverse event reporting, safety substantiation, and proper labeling. FDA has also proposed GMP regulations for cosmetics. The facilities that treat this as optional will be the ones scrambling when enforcement begins.
We have always made cosmetics without GMP. Where do we start?
With a baseline. Our four-week readiness assessment measures your operation against FDA's proposed GMP expectations: documentation, manufacturing controls, quality oversight, complaint handling, and record retention — then sequences the build so the highest-risk gaps close first.
Does MoCRA apply to small or indie brands?
Mostly yes. There are narrow exemptions for certain very small businesses, but facility registration, adverse event reporting, and labeling requirements still reach further than many brands assume. If you are unsure, the assessment answers it definitively.
Can you help with serious adverse event procedures?
Yes. Adverse event intake, evaluation, recordkeeping, and FDA reporting timelines are a core part of our cosmetics quality-system work — it is one of the areas where the industry is least prepared.
We also sell on Amazon and DTC. Does that change anything?
It raises the stakes. Online and retail distribution multiplies the number of consumers — and complaints — touching your product, which makes complaint handling and traceability more important, not less.
FREE DOWNLOAD
Get the Free Checklist
Find your gaps before an auditor does.
Our free 25-point Cosmetics GMP Checklist — the same questions auditors ask, as a yes/no self-check. Every unchecked box is a finding waiting to happen.
Build the system before it's required.
Start with a free readiness call — cosmetics focused. We'll walk through your top 3 GMP risks and give you an honest fit assessment. Confidential, no pressure.