The facts
On October 14, 2026, the FDA sent a warning letter (reference number 320-27-06) to Mr. Kunio Yamada over violations at Rohto-Mentholatum (Vietnam) Co., Ltd., FDA Establishment Identifier 3008808745, at No. 16 VSIP Street No. 5, Vietnam-Singapore Industrial Park, Thuan Giao Ward, Ho Chi Minh, Vietnam. The agency inspected the plant from April 6 to 14, 2026. The firm manufactures over-the-counter topical ophthalmic drug products using aseptic processing.
The inspection found what the letter calls "systemic data falsification." The plant's standard operating procedure required post-batch surface sampling, but the firm "acknowledged repeatedly submitting unexposed plates to the laboratory and confirmed that you did not perform the actual sampling." Personnel monitoring samples were not collected for production and engineering personnel who worked in the aseptic processing room; instead, "unexposed plates were submitted to the laboratory and the associated records reflected that personnel sampling had been performed." In a separate instance, active air samples for a batch were collected at incorrect locations but "falsely documented as having been collected at the required locations."
Cleaning records said ISO 5 surfaces were cleaned on January 23, January 30, March 10, and March 21, 2026. The inspection found no evidence the cleaning was performed, and management confirmed "the records reported false information."
Through all of this, the firm reported "0 colony-forming unit findings across all EM and PM sampling with the exception of a single deviation following a water leakage event." When inspectors ran actual plate readings during the inspection, from April 10 to 14, 2026, they got "numerous EM and PM samples with microbial growth, including approximately 25 ISO 5 excursions."
The FDA wrote that "The profound data integrity breaches at your firm critically undermined assurance of sterility for U.S.-distributed drug products", and deemed the products adulterated under section 501(a)(2)(B). The company told the agency it had suspended drug production for the U.S. market, notified its U.S. distributor to halt distribution, and acknowledged that EM, PM, and cleaning records were falsified. The FDA's answer: "Your response is inadequate." Among other reasons: "Falsified EM data cannot be used for trending analysis."
The letter also covers the company's marketing. After reviewing rohtoeyedrops.com and the @rohtoeyedrops Instagram account in August 2026, the FDA found seven products, "ROHTO® Cooling Eye Drops COOL RELIEF," "ROHTO® Cooling Eye Drops ALL-IN-ONE," "ROHTO® Cooling Eye Drops MAX STRENGTH," "ROHTO® Cooling Eye Drops DIGI EYE," "ROHTO® Cooling Eye Drops OPTIC GLOW," "ROHTO® Cooling Eye Drops DRY AID," and "ROHTO® Cooling Eye Drops DUAL LIGHT RELIEF", are "unapproved new drugs" and "misbranded".
Our take
Let’s get this straight: a factory making shit you drip into your fucking eyeballs decided that the best way to prove it was sterile was to not test a goddamn thing. They had a standard procedure for surface sampling after each batch. Their brilliant fucking workaround was to just send a clean, unexposed plate to the lab and check the box. They were supposed to swab the people working in the sterile room. Instead, they sent more blank plates and wrote down that the swabbing happened. They wrote down that they cleaned the most critical surfaces on four separate dates. They didn’t clean shit. Management looked at these fairy tales and said, yep, sign us up for that false information. This is a conspiracy of cowards so comprehensive it would be impressive if it weren’t for the part where they’re bottling potential eye infections.
And the sheer, breathtaking gall of the paperwork. While this symphony of lies was playing, the official record showed a perfect, beautiful zero. Zero colony-forming units. Across everything. Except, oh yeah, that one time there was a water leak - even their fiction needed a plot twist. Then the FDA inspectors showed up and actually exposed some plates. From April 10 to 14, 2026, they found microbial growth everywhere, including about 25 ‘excursions’ in the ISO 5 clean zone - the place that’s supposed to be the fucking sanctum sanctorum for sterile product. So the real record wasn’t zero; it was a petri dish buffet. The company’s data was so utterly fabricated that the FDA had to point out the fucking obvious: ‘Falsified EM data cannot be used for trending analysis.’ No shit. You can’t trend fantasy, you absolute cunts.
Then there’s the marketing department, living in a parallel universe of bullshit. While the plant was submitting blank plates as test results, the Instagram feed and website were pumping seven different ‘Cooling Eye Drops’ with names like ‘OPTIC GLOW’ and ‘DUAL LIGHT RELIEF’. The FDA took one look at those claims in August and declared them unapproved new drugs and misbranded. So the company failed at the basic task of making medicine honestly and failed at the basic task of selling it legally. It’s a perfect circle of incompetence and fraud.
The company’s response to getting caught was to say they’d stopped production for the U.S. and told their distributor to stop shipping. The FDA’s response to that response was ‘inadequate.’ Of course it’s inadequate. You can’t unfuck this by pressing pause. The ‘assurance of sterility’ was critically undermined because it was never there. It was a story they all agreed to tell, written on paper that was cleaner than their cleanrooms ever were. You were better off squeezing lemon juice in your eyes.
