Home / Who we serve / MoCRA readiness
MoCRA readiness
MoCRA made cosmetics a regulated operation.
The Modernization of Cosmetics Regulation Act brought facility registration, product listing, serious adverse event reporting, safety substantiation and mandatory recall authority. FDA is still writing cosmetic GMP rules. Claraxis helps manufacturers get the operation ready before they land.
MoCRA requirements per the statute; recall figure from Claraxis FDA Watch, 12 months to October 11, 2026.
The problem
Where cosmetics plants are exposed.
Quality systems built for a lighter regime
Batch records, investigations and change control that were fine before MoCRA but would not survive a drug-style inspection.
Listings that drift from reality
Product listings, formulas and the facility of manufacture change, and nobody owns keeping FDA records current.
Water and micro control
Microbial contamination is the leading cause of personal care recalls. Many cosmetics plants have never trended their water data.
How Claraxis helps
Readiness without the overhead.
- GMP habits now: batch records, investigations, change control, cleaning
- Purified water and microbial control review against USP requirements
- Inspection readiness: an FDA-style walk-through of the plant and its records
- Equipment, utility and process validation
- Registration, listing, adverse event and safety substantiation requirements: we flag the gaps in your operation and work alongside your regulatory specialist or counsel, who handle the filings
Who you work with
Kobe Ofori-atta, founder.
“Kobe’s assessment gave us the clarity we needed to move forward with confidence. His ability to quickly understand our operation and identify the highest-impact opportunities was impressive.”
Relevant experience
- Led a USP purified water system modernization and built a 24/7 real-time operational dashboard.
- Primary site FDA contact; hosted FDA inspections and quality audits, with zero major findings.
- Fractional business development for Coughlan Products, a contract manufacturer founded in 1900.
- Process engineering and compliance (2016–19): equipment and utility validation, GMP and EHS.
Roles held before founding Claraxis Group. Full background →
Questions
Answered.
Has FDA finalized cosmetic GMP regulations?
Not as of early 2026. MoCRA requires FDA to issue them, and drug-style expectations are a reasonable guide in the meantime. Claraxis tracks the rulemaking and updates guidance as it changes.
Who has to register under MoCRA?
Facilities that manufacture or process cosmetics for US distribution register with FDA and renew every two years. The responsible person lists each product and keeps safety substantiation records.
We also make OTC products. Does MoCRA change anything?
Products that are both drugs and cosmetics, such as sunscreens and anti-dandruff shampoos, already follow drug GMP. Plants that run both often find the cosmetic lines are the weaker system.
Is this legal advice?
No. Claraxis provides operational readiness support. Use regulatory counsel for legal interpretation and labeling claims.
The FDA Watch brief
Get this in your inbox every month.
What FDA cited, and the one thing to fix. 3-minute read, free.
Start with the real challenge.
A 30-minute call, then a written scope before any commitment. Kobe replies personally within one business day.