2026-09-22 FDA Warning Letter: Unilam Co., LTD Cited for CGMP/QSR/Medical Devices/Adulterated
Letter issued · posted to fda.gov .
Subject as published: CGMP/QSR/Medical Devices/Adulterated
TL;DR
The short version: **FDA Warning Letter to Unilam Co., LTD (CMS #738562, September 22, 2026)** The FDA's Center for Devices and Radiological Health cited Unilam Co., LTD, a South Korean manufacturer of SUV 600-800/KT/GYU UV Sunlamp medical devices, for adulteration under 21 U.S.C. § 351(h) following a May 18–22, 2026 inspection, finding violations of current good manufacturing practice requirements in 21 CFR Part 820 and ISO 13485:2016. Primary violations include: inadequate risk management procedures that fail to address design-level controls and foreseeable hazards such as chemical exposure from lamp breakage; incomplete design validation documentation lacking lifetime emissions data and formal design change controls; and insufficient supplier evaluation criteria in purchasing procedures. The FDA determined Unilam's June 15, 2026 response inadequate, noting that updated procedures and risk assessments still lack critical UVC emissions lifetime testing data and do not demonstrate consistent application of new controls to post-July 1, 2026 design changes.
Argus analysis
# FDA Warning Letter Analysis: Unilam Co., LTD
## Company and Findings
Unilam Co., LTD, a South Korean manufacturer of UV sunlamp devices (SUV 600-800/KT/GYU model), received a warning letter from the FDA's Center for Devices and Radiological Health on September 22, 2026, following an inspection conducted May 18–22, 2026. The FDA determined that Unilam's devices are adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act because manufacturing methods, facilities, and controls fail to comply with current good manufacturing practice requirements.
## Regulatory Citations and Meaning
The violations cite 21 CFR Part 820 (Quality System Regulation) and reference ISO 13485:2016 standards. Specific deficiencies include inadequate risk management (ISO 13485 Clause 7.1), insufficient design and development documentation (Clause 7.3.1), poor supplier evaluation and control (Clauses 7.4.1 and 7.4.2), and inadequate monitoring and measurement procedures (Clause 7.6). These violations indicate systemic gaps: risk assessments addressing only four failure modes instead of foreseeable hazards like chemical exposure from lamp breakage; missing validation data for UV emission performance over the device's full 800-hour lifetime; suppliers approved without proper vetting or binding change-notification agreements; and equipment calibration procedures excluding the UV wavelengths the devices actually emit.
## Expected Response Timeline
Companies typically have 15 business days to respond to warning letters. Compliance officers monitoring Unilam should watch for whether the firm submits adequately documented corrective actions addressing design validation data gaps, revised supplier agreements with binding change-notification language, and recalibrated measurement equipment spanning UV wavelengths. Key indicators of progress include evidence that design control procedures apply to all post-July 2026 changes and retroactive assessment of product potentially affected by the 2021 supplier change and post-fire equipment requalification failures.
Severity context
High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
Regulatory background
CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER Unilam Co., LTD MARCS-CMS 738562 — September 22, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Joo-Young Yoon Recipient Title CEO Unilam Co., LTD Ulju-gun Ulsan South Korea (b)(6)@unilam.co.kr Issuing Office: Center for Devices and Radiological Health United States WARNING LETTER CMS #738562 September 22, 2026 Dear Mr. Yoon, During an inspection of your firm located in Ulju, Ulsan, South Korea, from 05/18/2026 through 05/22/2026, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures SUV 600-800/KT/GYU UV Sunlamp, Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body. Quality System Regulation Violation(s) This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from Young Boo Cho dated June 15, 2026, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following: 1. Failure to establish, implement, and maintain one or more processes for risk management in product realization, as required by ISO 13485:2016 Clause 7.1. For example: Your firm does not have a risk management procedure that addresses design controls. Additionally, your firm's DFMEA only addresses 4 risk line items, and the risk controls identified rely almost entirely on labeling or on actions only able to be undertaken by the downstream sunlamp bed manufacturer, such as use of a timer or UV filter, rather than design level controls within your firm's own manufacturing process. The limited scope of the DFMEA results in a failure of the DFMEA to include reasonably anticipated failure modes. Furthermore, your firm's DFMEA does not address foreseeable risks, such as chemical exposure in the event of lamp breakage. By relying only on risk control measures involving labeling or actions outside the manufacturer’s control, your firm cannot ensure that those control measures will effectively bring the associated residual risks to an acceptable level. We reviewed your firm’s response and conclude that it is not adequate. Your firm crea…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- Has Unilam Co., LTD had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Unilam Co., LTD as of 2026-10-06. Argus ingests new FDA enforcement records daily.
- What FDA violations was Unilam Co., LTD cited for?
- The FDA Warning Letter to Unilam Co., LTD (issuing office: Center for Devices and Radiological Health) cites: CGMP/QSR/Medical Devices/Adulterated. Classification: CGMP — Current Good Manufacturing Practice.
- When did FDA issue the warning letter to Unilam Co., LTD?
- FDA issued the letter (MARCS-CMS 738562) on 2026-09-22 and posted it publicly on fda.gov on 2026-10-06.
- Is the FDA warning letter to Unilam Co., LTD publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/unilam-co-ltd-738562-09222026.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). 2026-09-22 FDA Warning Letter: Unilam Co., LTD Cited for CGMP/QSR/Medical Devices/Adulterated. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-unilam-co-ltd-2026-09-22-cgmp
"2026-09-22 FDA Warning Letter: Unilam Co., LTD Cited for CGMP/QSR/Medical Devices/Adulterated." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-unilam-co-ltd-2026-09-22-cgmp.
Argus HQ Research. "2026-09-22 FDA Warning Letter: Unilam Co., LTD Cited for CGMP/QSR/Medical Devices/Adulterated." Digital Empire Holdings LLC. Accessed October 7, 2026. https://argushq.ai/fda/warning-letter/fda-wl-unilam-co-ltd-2026-09-22-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_unilam_co_ltd_2026_09_22_cgmp_2026,
title = {2026-09-22 FDA Warning Letter: Unilam Co., LTD Cited for CGMP/QSR/Medical Devices/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-unilam-co-ltd-2026-09-22-cgmp},
note = {Accessed: October 7, 2026}
}