Rohto Pharmaceutical Receives FDA Warning Letter After Vietnam Facility CGMP Failures

Rohto Pharmaceutical Co., Ltd. is now managing a dual-front FDA enforcement action that implicates both its Vietnam manufacturing operation and the labeling of seven OTC eye drop lines sold in the U.S. market. The October 14, 2026 warning letter, addressed to Chairman Kunio Yamada, follows an April 2026 inspection of Rohto-Mentholatum (Vietnam) Co., Ltd. and a separate August 2026 review of product labeling and digital marketing channels.

Inspectors documented CGMP violations under 21 CFR Parts 210 and 211 at the Ho Chi Minh facility (FEI 3008808745), citing failures to maintain complete laboratory records across all tests necessary to confirm specification compliance, and inadequate cleaning, maintenance, and sanitization of equipment at intervals sufficient to prevent contamination or product adulteration. Under section 501(a)(2)(B) of the FD&C Act, the agency has classified the facility's drug products as adulterated.

The labeling review added a second layer of regulatory exposure. FDA determined that seven ROHTO® Cooling Eye Drops SKUs, including Cool Relief, Max Strength, Digi Eye, Optic Glow, Dry Aid, All-In-One, and Dual Light Relief, are unapproved new drugs under section 505(a) of the FD&C Act and misbranded under sections 502(a) and 502(ee). The agency flagged both the company's rohtoeyedrops.com website and its Instagram account as sources of non-compliant claims, a detail that will concern regulatory affairs leads managing digital promotional content alongside traditional labeling.

Rohto submitted a response to the Form FDA 483 on May 1, 2026, which FDA acknowledged but found insufficient to close the inspection cycle. The warning letter is explicit that failure to adequately address violations may result in further regulatory action without additional notice, a posture that signals limited tolerance for incremental remediation plans.

For QA directors and plant heads with contract or affiliate sites in Southeast Asia, the inspection record reinforces the agency's sustained scrutiny of foreign OTC drug manufacturers supplying the U.S. market, particularly around laboratory data integrity and equipment qualification under ICH Q10-aligned quality systems.

The measurable checkpoint ahead is Rohto's formal written response to the warning letter, which will determine whether FDA pursues import alerts, injunctive action, or accepts a corrective action plan covering both the manufacturing deficiencies and the unapproved drug status of the seven eye drop lines.

Source: FDA Center for Drug Evaluation and Research (CDER) via FDA Warning Letters database, October 20, 2026. Warning letter reference number 320-27-06, issued October 14, 2026.