WARNING LETTER

Leltek Inc. MARCS-CMS 710787 — July 17, 2025

Delivery Method:: Via Email
Product:: Medical Devices

Recipient:: Recipient Name

Kuo-Ping (Michael) Liu; Recipient Title

President and CEO; Leltek Inc.; 6F.-3, 293 Beixin Road, Section 1
Xindian District, New Taipei City 23147
Taiwan; michael.liu@leltek.com

Issuing Office:: Center for Devices and Radiological Health; United States

WARNING LETTER

July 17, 2025

Dear Mr. Kuo-Ping (Michael) Liu:

During an inspection of your firm located in New Taipei, Taiwan on March 3, 2025, through March 6, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Ultrasound Imaging System LU700 Series and Ultrasound Imaging System LK128 Series. 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 any function of the body.

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 Paul Chang, Manager, dated March 18, 2025, 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 adequately establish and maintain procedures for implementing corrective and preventative action (CAPA), as required by CFR 820.100(a)(1). For example, your firm’s procedure, “Change and corrective precautions control procedures – LK-QP-022 Edition E”, lacks a methodology to trend and analyze quality data sources and initiate CAPA’s depending on the criticality reported device problems present in finished device safety and performance. Specifically, despite repair rates in excess of 55% for your firm’s ultrasound systems, CAPAs were not initiated. The repairs covered software, printed circuit board assemblies (PCBA), and lithium batteries.

We reviewed your response and conclude it is not adequate. Your response acknowledges procedural deficiencies with quality data analysis procedures to consider risk and establish quantitative thresholds for initiating corrective action projects. Your firm proposes to revise procedures related to data analysis control program for data analysis. However, your response does not address the nature of device failures and associated risks that resulted in device repairs cited during the inspection, the correlation with other procedural deficiencies and the CAPA procedure, a retrospective assessment of previously reported non-conformities, a timeframe for completion of corrective actions and training of employees on new procedures.

2. Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically, your firm failed to capture and evaluate complaints (received via the Complaint Record Form) in accordance with complaint handling requirements. For example, your firm failed to conduct complaint investigations associated with image anomalies, abnormal temperature display, abnormal power consumption, probe overheating, battery drain, serious overheating, and loud noises. Additionally, multiple complaint files did not contain root cause analyses or assessments for potential reporting under 21 CFR Part 803. Furthermore, these records were not captured as complaint files, rather only as “repairs/ exchange”.

We reviewed your response and conclude it is not adequate. Your response does not address procedural deficiencies to adequately identify any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution as a complaint. No information is contained in the response in relation to the root cause for the reported device failures cited in the observation and an evaluation of their risk as it relates to the device use conditions at time the complaints were reported. In addition, the response does not address a timeframe for revising procedures or to conduct employee training.

3. Failure to adequately establish purchasing control procedures to ensure that all contractors, including contract manufacturers of your Leltek Ultrasound Device Systems are evaluated based on their ability to meet specified and quality requirements, as required under 21 CFR 820.50(a). Specifically, your firm failed to follow established purchasing control procedures to evaluate and implement controls to be exercised over contract manufacturers of finished ultrasound systems in order to determine their ability to meet required device specifications, and before initiating production activities.

We reviewed your response and conclude it is not adequate. Your response states that the root cause that led to the observation was that a form required to be filled out for outsourcing manufacturing activities was deficient, because it did not require that contract manufacturers (“the supplier”) passed ISO 13485 or GMP manufacturing specifications. However, the response does not address what are the defined requirements for contact manufacturers, as it relates to supplier classification criteria and in relation to the impact outsourced production activities represent for finished devices. Specifically, your response does not include information regarding the criticality to be assigned to contract manufacturers and requirements to qualify these suppliers per established procedures. In addition, the response does not include an evaluation of previous quality data sources indicative that the suppliers have met requirements intended to ensure finished devices conform to required specifications. Your response does not specify a timeframe to revise procedures for outsourcing of manufacturing activities or to train employees.

4. Failure to adequately establish and maintain procedures for acceptance activities, as required by 21 CFR 820.80(a). For example:

a. Electronic DHR testing forms for the Leltek Ultrasound Imaging Systems were pre-filled with the test results (i.e., “PASS”), the signature of the operator, the personnel, and the person “Approved for release.”

b. DHR testing forms (e.g., #B24940401) for your firm’s Leltek Ultrasound Imaging Systems failed to include records of inspection, test, and/or other acceptance activities for critical components such as lithium battery, probe, and printed circuit boards. The DHR’s reviewed also failed to include the identifiers (serial / lot numbers) for components consumed to manufacture finished device units.

We reviewed your response and conclude it is not adequate. Your response does not provide raw data generated during production and corresponding to DHRs reviewed during the inspection, to confirm devices were manufactured according to the requirements in the DMR. Furthermore, there are no records contained in your response to demonstrate data obtained during production for device units previously distributed can be retrieved and verified against required product and production requirements to ensure devices complied with required specifications. Additionally, your response acknowledges a corrective action will be implemented to add serial numbers of “key parts” to DHRs. Further, the response does not address if acceptance activities for components will also become part of DHRs. In addition, your response does not provide a timeframe to revise DHR templates, examples of new templates that will include component acceptance activities and identifiers, and does not provide information of how employees will be trained on new requirements for documenting relevant information on DHRs.

5. Failure to establish and maintain a Design History Files (DHF) for each type of device, as required under 21 CFR 820.30(j). Specifically, your firm failed to establish Design History Files for the LK128 Series and the LU700 Series ultrasound imaging systems.

We reviewed your response and conclude it is not adequate. Your response documents that because its records control procedure did not distinguish the DHF was to be documented in hard copy format, this was not centralized or kept as a record. The response indicates that its records control procedure needs to be corrected. However, no evidence in the form of either physical or electronic records were provided with your response to evidence the existence of DHF’s for your firm’s devices and that this encompassed documented evidence of required activities under 21 CFR 820.30 – Design Controls. Furthermore, your response does not indicate a timeframe as it relates to implementing procedure corrections, review of other Design History Files against procedural requirements, employee training on revised procedures and/or additional systemic corrective actions to be implemented.

6. Failure to adequately implement production and process control procedures to ensure conformance to specifications have been met, as required under 21 CFR 820.70(a). Specifically, your firm did not include all necessary assembly steps on manufacturing instructions for the LU700 Series Diagnostic Ultrasound Systems. Your firm’s LU700 Assembly Operation Specifications, Document #LK_QI-AMY-001, Revision G, failed to include production steps to (b)(4) and other device components.

We reviewed your response and conclude it is not adequate. Your response indicates that the (b)(4) during production. Your firm’s response acknowledges the assembly steps were not included within manufacturing instructions. Your firm proposes to add the missing steps to work instructions. However, your response does not comprehensively address if additional manufacturing steps were missing from the manufacturing instructions, the potential impact of misconnection between components as it relates to finished devices, or an evaluation of previous production lots to determine if (b)(4) resulted in non-conformities. The response is not specific on timeframes for revising manufacturing instructions and conducting employee training accordingly.

7. Failure to adequately establish procedures for the control of labeling operations to ensure that the label and labeling used for each production unit, lot, or batch is documented in the Device History Record (DHR), as required under 21 CFR 820.120(d). Specifically, DHRs pertaining to your firm’s Leltek Ultrasonic Imaging Systems failed to include or refer to the location of the label and labeling applied to each production unit, lot, or batch.

We reviewed your response and conclude it is not adequate. Your response states that current procedures only require that the labeling, including labels applied to devices are verified for accuracy during quality control operations. The response also points to the lack of requirements to consider the traceability of labeling to related records and product shipments. Your firm’s response states plans to update the DHR format to attach a “UDI list” to the corresponding batch. However, your response does not provide a timeframe to revise the DHR labeling content requirements, a timeframe to train employees on new requirements, the revised DHR format, and a retrospective review of data sources that would indicate if labeling non-conformities have previously occurred during production.

Our inspection also revealed that your firm has failed to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example, during the inspection, we reviewed your firm’s document titled “Procedures for Advisory notification and adverse event reporting control” (LK_QP‐017, Edition D), dated 2022.06.12, which was identified as its written MDR procedure. The following deficiencies were noted:

8. The procedure LK_QP‐017, Edition D, does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). For example:

a. The procedure LK_QP‐017, Edition D, does not include adequate definitions of what constitutes a reportable event under 21 CFR Part 803. The fact that the procedure does not include definitions from 21 CFR 803.3 for the terms “become aware”, “caused or contributed”, “malfunction”, “MDR reportable event”, and “serious injury”, and the definition found in 21 CFR 803.20(c)(1) for the term “reasonably suggests”, may lead your firm to make an incorrect reportability decision when evaluating a complaints that may meet the criteria for reporting under 21 CFR 803.50(a).

b. The procedure LK_QP‐017, Edition D, provides general requirements on what events should be evaluated for MDR reportability; however, it lacks detailed, step-by-step instructions for employees to follow.

9. The procedure LK_QP‐017, Edition D, does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part, as required by 21 CFR 803.17(a)(2). For example,

The procedure, as written, does not specify who makes the decision for reporting events to FDA.

10. The procedure LK_QP‐017, Edition D, does not establish internal systems that provide for timely transmission of complete medical device reports, as required by 21 CFR 803.17(a)(3). Specifically, your procedure does not include:

a. Instructions for how your firm will comply with 21 CFR 803.12(a)’s requirement to submit reports to FDA in an electronic format that the FDA can process, review, and archive.

b. The circumstances under which your firm must submit initial 30 days, supplement or follow-up, and 5‐day reports, as required by 21 CFR 803.10; and the requirements for such reports, as required by 21 CFR 803.52.

11. The procedure LK_QP‐017, Edition D, does not describe how your firm will address documentation and record‐keeping requirements, as required by 21 CFR 803.17(b), including:

a. Documentation of adverse event related information maintained as MDR event files, as required under 21 CFR 803.18(b)(1).

b. Documentation of information that was evaluated to determine if an event was reportable.

c. Documentation of the deliberations and decision‐making processes used to determine if a device‐related death, serious injury, or malfunction was or was not reportable, as required under 21 CFR 803.18(b)(1)(i).

The adequacy of your firm’s response cannot be determined at this time. While the response notes a correction plan to establish a procedure “in accordance with the latest version of regulations”, revised procedures, an analysis of previously reported complaints to determine if these met the definition of reportable events, and records of employee training on revised procedures were not provided.

A device is deemed to be misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), if there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, which includes adverse event reports required under 21 CFR Part 803, respecting the device.

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 Assistant Director Yanna Kang, PhD, at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case # 710787” when replying. If you have any questions about the contents of this letter, please contact: Laiza V. Garcia, Reviewer at laiza.garcia@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 yours,
/S/

Robert Ochs, Ph.D.
Director
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Cc:
Chi-Feng Chang
U.S. Agent
Qualtech Consulting LLC
532 Arboles St.
Monterey Park, California 91754
(b)(4)@qualtechs.com