Unilam Co., LTD

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 created three new risk management procedures (2D4-014, 2D4-014-01, and 2D4-007-10), updated its DFMEA to evaluate additional potential failure modes and risk controls for its SUV lamps, and trained personnel on ISO 13485 and ISO 14971. However, the updated DFMEA still does not address the foreseeable risk of chemical exposure in the event of lamp breakage. Additionally, several risks in the updated DFMEA were accepted at medium-risk RPN levels without the design verification test data and technical manager approvals required by your firm's own procedure 2D4-007-10.

2. Failure to adequately document design and development procedures, as required by ISO 13485:2016 Clause 7.3.1.

For example: Your firm has not documented validation plans that include methods, acceptance criteria, rationale for sample size, rationale for choice of product, or confirmation that validation was conducted on a representative product. Your firm performed a lifetime test intended to serve as design validation following a change to its quartz tube supplier; however, the documents do not include the previously listed information and do not include results for UVC emissions over the full 800-hour expected lifetime of the device. Furthermore, your firm does not have procedures to control design and development changes. Specifically, your firm's quality manager stated that your firm does not have a design control procedure.

We reviewed your firm’s response and concluded that it is not adequate. Your firm created a new procedure, 2D4-007-10 (SUV Design and Review Preparation Instruction, Ver. 00), outlining how to plan and document design validation, evaluate design changes, linked those changes to risk management, and performed risk assessments for the three design changes identified during the inspection. However, your firm has not provided test data showing that UVC emissions remain within acceptable limits over the full 800-hour lifetime of the device. Additionally, your firm's risk assessment for ECN 21-00472 states the 2021 post-fire change only involved resetting inspection values and did not affect lamp performance. However, this change also included modifications to the UVA and UVB product specifications, and your firm has not explained why those specifications changed or whether the change affected product safety. Finally, your firm has not provided evidence that 2D4-007-10 has been applied to any design changes made after its effective date of July 1, 2026, and it cannot be confirmed whether the existing change control process reliably triggers its use for all SUV medical device design changes.

3. Failure to adequately establish criteria for the evaluation and selection of suppliers, as required by ISO 13485:2016 Clause 7.4.1.

For example: Your firm's purchasing procedures (Purchasing Management Procedure, 2D3-001, Rev. 18; Supplier Management Procedure, 2D3-002, Rev. 16) do not establish criteria for initial evaluation and selection of suppliers prior to use.

We reviewed your firm’s response and concluded that it is not adequate. Your firm completed initial supplier evaluations for its quartz tube, mercury, and krypton suppliers. However, the evaluation form for the quartz tube supplier ((b)(4)) scored 80 points, which is the minimum passing threshold, but was marked "Not Registered." This is contradictory and raises doubt about whether this supplier was approved. Furthermore, the evaluation form for the mercury supplier references both (b)(4), which is the supplier of record, and (b)(4), which makes it unclear which entity was evaluated.

4. Failure to maintain written agreements requiring suppliers to notify the firm of changes to purchased product prior to implementation, as required by ISO 13485:2016 Clause 7.4.2.

For example: Your firm has not established written change notification agreements with its suppliers of quartz tube, mercury, and krypton. These are key raw materials that directly affect the UV emission characteristics and safety performance of its sunlamp products. In the absence of such agreements, your firm has no assurance that it will be notified of supplier changes prior to those changes impacting the sunlamp products, and therefore no opportunity to assess whether requalification or updated certification testing is required before affected product is distributed.

We reviewed your firm’s response and concluded that it is not adequate. Your firm updated its purchase order form to require suppliers to notify your firm before making changes. However, the change notification language added to the purchase order form is a one-sided request rather than a binding mutual agreement. This is less comprehensive than what your firm described in its response, which stated the purchase order form would cover changes to specifications, materials, manufacturing process, manufacturing location, and sub-suppliers.

5. Failure to adequately document procedures to ensure that monitoring and measurement can be carried out and are carried out in a manner consistent with monitoring and measurement requirements, as required by ISO 13485:2016 Clause 7.6.

For example: Your firm did not include the actual range of use for the Integrating Sphere test equipment (OL770) in your firm's calibration acceptance criteria. Although your firm collects calibration data from 195–793 nm, the acceptance criteria for new calibration curves are based solely on the visible light spectrum (340–780 nm). However, this equipment is used to measure UVC (200–260 nm) and UVB (260–320 nm) emissions required by the performance standard. These wavelengths are excluded from your firm's acceptance criteria and exhibit substantially higher variation than the visible spectrum. Furthermore, after a fire at the factory in 2021, your firm did not perform an adequate requalification of the Integrating Sphere equipment (OL770). While a calibration record was generated after cleaning, there was no justification for the acceptability of the post cleaning irradiance reading, no documented basis for concluding that the cleaning did not adversely affect the instrument's functionality, and no additional equipment qualification was performed. Finally, the calibration procedures do not define how to assess the validity of previous testing results when testing equipment is found out of calibration, nor do they define how to handle any potentially affected product.

The adequacy of your firm’s response cannot be determined at this time. Your firm established a Sampling Plan Validation Protocol (VAL-PRO-001, Rev. 0) and Validation Report (VAL-RPT-001, Rev. 0) to retroactively provide the documented statistical and manufacturing basis that was absent. However, the process capability analysis is not explicitly linked to the parameters and acceptance criteria required under the applicable performance standard. The rationale for limiting 100% verification to five lots is not documented. Your firm has not revised its AQL Inspection Level Setting Guideline (2S2-008-01) to require prospective statistical justification for future sampling plan selections. Finally, the validation report does not address whether the continued use of sampling based inspection is consistent with the regulatory expectation that all SUV lamps conform to the applicable performance standard.

6. Failure to monitor and measure the characteristics of the product to verify that product requirements have been met, as required by ISO 13485:2016 Clause 8.2.6.

For example: Your firm's sampling plan for certification testing of SUV lamps, as described in procedure AQL Inspection Level Setting Guideline, 2S2-008-01, is based on ISO 2859-1 at AQL 2.5 using Table S-3. However, your firm has not established a documented statistical or manufacturing basis for the selection of this sampling level.

For example: Your firm's sampling plan for certification testing of SUV lamps, as described in procedure AQL Inspection Level Setting Guideline, 2S2-008-01, is based on ISO 2859-1 at AQL 2.5 using Table S-3. However, your firm has not established a documented statistical or manufacturing basis for the selection of this sampling level.

We reviewed your firm’s response and concluded that it is not adequate. Your firm established a Sampling Plan Validation Protocol (VAL-PRO-001, Rev. 0) and Validation Report (VAL-RPT-001, Rev. 0) to retroactively provide the documented statistical and manufacturing basis that was absent. However, the process capability analysis is not explicitly linked to the parameters and acceptance criteria required under the applicable performance standard; the rationale for limiting 100% verification to five lots is not documented; your firm has not revised its AQL Inspection Level Setting Guideline (2S2-008-01) to require prospective statistical justification for future sampling plan selections and the validation report does not address the continued use of sampling based inspection with the regulatory expectation that all SUV lamps conform to the applicable performance standard.

ELECTRONIC PRODUCT RADIATION CONTROL DEVICE VIOLATION(S)
The Center for Devices and Radiological Health has determined the SUV 600-800/KT/GYU UV Sunlamp fails to comply with the federal requirements found in 21 Code of Federal Regulations (CFR) Part 1040 and 21 CFR Part 1010. In addition to being a "device," SUV 600-800/KT/GYU UV Sunlamps is an "electronic product" subject to compliance with Subchapter C of the Act, Electronic Product Radiation Control, the general requirements at 21 CFR 1000-1005, and the performance standards at 21 CFR 1010, and 1040.20. Your firm failed to comply with the regulations regarding the testing of the product for determination of compliance with the regulations, as follows:

Per 21 CFR 1040.20(f), tests on which certification pursuant to 21 CFR 1010.2 is based shall account for all errors and statistical uncertainties in the process and, wherever applicable, for changes in radiation emission or degradation in radiation safety with the age of the product. Measurements for certification purposes shall be made under those operational conditions, lamp voltage, current, and position as recommended by the manufacturer. For these measurements, the measuring instrument shall be positioned at the recommended exposure position and so oriented as to result in the maximum detection of the radiation by the instrument. In response to Form FDA 483 issued at the conclusion of the inspection, your firm states that “the measurement method follows the measurement principles of CIE 127 and CIE S 025, and defines the measurement sequence, equipment configuration, operating conditions, aging/stabilization before measurement, data recording, and acceptance determination against the applicable specification.” However, even though document “2S2-008-05 SUV In-Process Inspection Work Instruction, Ver.00.pdf” presents a detailed test procedure based on CIE 127 and CIE S 025 international standards, it appears that key procedural details, such as measurement geometry, calibration, and stabilization criteria, are absent or not adequately documented. Also, several critical requirements such as temperature control, supply tolerances, calibration traceability, sphere correction factors, are not addressed in the measurement test procedure submitted by your firm. Additionally, the testing procedure mentions that aging is performed, but we could not find documented evidence on how the aging of the product is conducted.

Documents “2D4-007-10 SUV Design and Review Preparation Instruction, Ver.00.pdf” and “SUV Design and Review Experimental Plan Form, Ver.00.pdf” do not appear to provide a clear justification for why this emissions set-up is the worst-case scenario for all models of UV lamps. Also, we could not find in your response any documented evidence providing justification of the sampling plan for the certification testing of your firm’s product along with statistical validation. We could not find the cited document “Sampling Plan Validation Protocol for SunLamps, VAL-PRO-001, Rev.OJ.pdf” in your firm’s submission.

Please be advised that, by authority of the Federal Food, Drug, and Cosmetic Act, Chapter V, Subchapter C – Electronic Product Radiation Control, manufacturers of sunlamps are responsible for assuring their products comply with all applicable mandatory federal radiation safety performance standards prior to entry of those products into US commerce. The applicable performance standards are 21 CFR Parts 1010, and 1040.20. Additionally, manufacturers of these products are subject to all applicable requirements of 21 CFR 1000 – 1005, which includes the reporting and record keeping requirements found in 21 CFR 1002.

Please provide the following information: (a) documented evidence on measurement geometry, calibration, stabilization criteria, temperature control, supply tolerances, calibration traceability, and sphere correction factors, (b) documented evidence on how the aging of the product is conducted, (c), a clear justification for why this emissions set-up is the worst-case scenario for all models of UV lamps. and (d) documented evidence on the justification of the sampling plan for the certification testing of your firm’s product along with statistical validation.

Copies of the Federal Performance Standards, compliance guides, radiation safety product report guides, and other documents related to sunlamps are available on FDA’s web site at: http://www.fda.gov/Radiation-EmittingProducts/default.htm.

Other federal agencies may take your compliance with the FD&C Act and its implementation regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective action (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent via email to Tanisha Hithe at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, CMS Case 738562 when replying. If you have any questions about the contents of this letter, please contact: Andrew Keys at Andrew.Keys@FDA.HHS.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.

Sincerely,  
/S/ 
Anton E. Dmitriev, PhD, MSc, FAIMBE  
Director  
OHT 4: Office of Surgical and Infection Control Devices  
Office of Product Evaluation and Quality  
Center for Devices and Radiological Health

CC:
Soojung Moon  
Allura Medical Solution Inc.  
5485 Rathdrum Way 
Antioch, CA 94531  
CC: (b)(6)@allurameds.com