The FDA is Cracking Down on Sunscreen Factories—Is Yours Truly Ready?

Lately, the FDA has been issuing a wave of Warning Letters to OTC sunscreen manufacturers. Korean manufacturers are no exception. Across all these letters, the core issue remains exactly the same: It’s not just about a faulty product; the entire manufacturing quality system is failing to function.

In South Korea, sunscreen is classified as a "functional cosmetic." Because of this, many brands and manufacturers mistakenly assume: "We passed the SPF testing, so we should be fine in the U.S., right?"

But here is the catch: The U.S. FDA regulates sunscreen as an OTC (Over-the-Counter) Drug.

This means the entire manufacturing facility must strictly comply with 21 CFR Parts 210/211—otherwise known as CGMP (Current Good Manufacturing Practice) regulations for pharmaceuticals. While Korean facilities operate under cosmetic GMP, the U.S. demands drug-level CGMP. It is an entirely different regulatory bracket. This is why a factory that runs flawlessly under Korean standards must review its entire setup from scratch to meet U.S. requirements.

The FDA’s Current Microscope is on Sunscreens

In 2025, the FDA issued a total of 470 Warning Letters, with OTC products making up the largest single category at 61 cases. Sunscreen manufacturers were repeatedly cited, and this aggressive enforcement trend continues well into 2026. The FDA is targeting facilities globally—whether in Korea, the U.S., or China.

The violations cited in these Warning Letters are shockingly consistent:

• Failure to test the assay/strength of active ingredients before releasing a batch.

• Relying solely on the supplier’s Certificate of Analysis (CoA) without conducting independent identity testing on raw materials.

• Having a Quality Unit (QU) on paper, but failing to let it function with actual authority.

• Lacking real-time or accelerated stability data to support the product's expiration date.

Brand owners who outsource their production are not safe either. In one recent case, a brand owner continued to distribute a batch even after the CMO notified them of elevated impurity levels. The FDA held the brand owner equally accountable for the CGMP violation.

What the FDA Actually Inspects

1. Is your Quality Unit (QU) truly operational? Your facility must have an independent quality department that holds the final, absolute authority to approve or reject product releases. If a QU exists only on organizational charts but gets routinely bypassed on the factory floor, the FDA considers it non-existent.

2. Are you testing every single batch? Even for the exact same formulation, every production batch must be tested and logged for active ingredient content and microbial contamination. Passing a test once does not clear future batches. You must have verifiable records proving this month’s batch actually meets the labeled SPF before it leaves the warehouse.

3. Are you independently verifying raw materials? Accepting a supplier's CoA at face value is a major red flag. The facility must run its own identity testing upon receiving raw materials. Furthermore, components with a high risk of contamination—like Glycerin—require strict limit testing. Trusting your supplier is one thing; verifying them is a regulatory mandate.

4. Can you prove your expiration date? If your bottle says "24 Months," you must back that up with hard stability data proving the formula remains effective for those 24 months. For sunscreens, this means proving the SPF protection doesn't degrade over time. Standard industry practice or assumptions won't cut it during an inspection.

5. Is your manufacturing process consistent every time? You must prove that your manufacturing processes are fully documented, strictly followed, and yield uniform results every single time. If batch records are incomplete or look retroactively filled out, the FDA will lose trust in your facility’s entire data integrity.

What Happens If You Get a Warning Letter?

If an Import Alert is issued, every single product manufactured at that facility will be detained immediately at the U.S. border. This applies to existing inventory, shipments currently at sea, and containers that just departed. For a brand, this triggers a catastrophic domino effect: Amazon listings get pulled, retail buyer contracts are breached, and consumer trust plummets.

Once a Warning Letter lands, the manufacturer has just 15 working days to submit a comprehensive corrective action plan. The import ban will remain firmly in place until the FDA conducts a re-inspection to verify the fixes—a process that typically takes several months, if not longer.

Why You Need to Audit Your Facility and Products Right Now

FDA inspections happen without prior notice. Dealing with the fallout—Warning Letters, corrective action responses, and waiting for re-inspections—costs exponentially more time and money than building a compliant system from the start. If you are already in the U.S. market or preparing to launch, auditing your system right now is the most cost-effective business decision you can make.

How Provision Consulting Group Can Help

Provision Consulting Group provides hands-on, practical support for cosmetics and pharmaceutical manufacturers looking to navigate U.S. market entry and ace FDA inspections—including OTC sunscreens.

Warning Letters arrive without warning. But your preparation can start today. Contact us anytime to secure your compliance.

For inquiries or expert assistance, please contact us today.

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