LEVO AG

During an inspection of your firm located in Wohlen, Switzerland on April 7, 2025, through April 9, 2025, an investigator from the United States (U.S.) Food and Drug Administration (FDA) determined that your firm manufactures the LEVO C3; LEVO Combi; LEVO LAE; and LEVO LCEV, Class II Standup Wheelchairs. 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.

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. This inspection also revealed that your firm failed to adequately establish and maintain medical device report procedures, as required by 21 C.F.R. § 803.17. Additionally, this inspection revealed that the labeler of these devices did not provide the information required by the subpart for each version or model required to bear a unique device identifier as required by 21 C.F.R. § 830.300.

We received a response from Heinz Bogli, Chief Operating Officer, dated April 29, 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 establish and maintain a quality system that is appropriate for the specific medical devices designed and manufactured as required by 21 CFR 820.5.

For example: Your firm, a medical device manufacturer of Class II Standup Wheelchairs, which are Class II medical devices subject to special controls as per 21 CFR 890.3900, has not established a Quality System per 21 CFR Part 820, to include Quality System procedures and instructions. Additionally, your firm does not meet the requirements of Current Good Manufacturing Practices (CGMP) set forth by the Quality System regulation to ensure the medical devices exported and intended for the U.S. market are safe and effective. Documentation pertaining to the following requirements were missing:

a) Subpart B – Quality System Requirements. Specifically:i. You did not have documentation to establish Management Responsibility, per 21 CFR 820.20.ii. You did not have documentation to establish Quality Audits, per 21 CFR 820.22.iii. You did not have documentation to establish requirements for Personnel, including background, training, and experience, per 21 CFR 820.25.

b) Subpart C – Design Controls. Specifically, you did not have documentation to establish Design Controls, per 21 CFR 820.30.

c) Subpart D – Document Controls. Specifically, you did not have documentation to establish Document Controls, per 21 CFR 820.40.

d) Subpart E – Purchasing Controls. Specifically, you did not have documentation to establish Purchasing Controls, per 21 CFR 820.50.

e) Subpart F – Identification and Traceability. Specifically:i. You did not have documentation to establish requirements for product Identification during production, per 21 CFR 820.60.ii. You did not have documentation to establish requirements for product Traceability during production, per 21 CFR 820.65.

f) Subpart G – Production and Process Controls. Specifically:i. You did not have documentation to establish Production and Process Controls, per 21 CFR 820.70.ii. You did not have documentation to establish requirements for Inspection, Measuring, and Test Equipment, per 21 CFR 820.72.iii. You did not have documentation to establish requirements for Process Validation, per 21 CFR 820.75.

g) Subpart H – Acceptance Activities. Specifically:i. You did not have documentation to establish requirements for Receiving, In-Process, and Finished Device Acceptance, per 21 CFR 820.80.ii. You did not have documentation to establish requirements for product Acceptance Status, per 21 CFR 820.86.

h) Subpart I – Nonconforming Product. Specifically, you did not have documentation to establish procedures for Nonconforming Products, per 21 CFR 820.90.

i) Subpart J – Corrective and Preventive Action. Specifically, you did not have documentation to establish procedures for Corrective and Preventive Actions, per 21 CFR 820.100.

j) Subpart K – Labeling and Packaging Controls. Specifically: i. You did not have documentation to establish requirements for Device Labeling, per 21 CFR 820.120.ii. You did not have documentation to establish requirements for Device Packaging, per 21 CFR 820.130.

k) Subpart L – Handling, Storage, Distribution, and Installation. Specifically:i. You did not have documentation to establish requirements for Handling of your devices, per 21 CFR 820.140.ii. You did not have documentation to establish requirements for Storage of your devices, per 21 CFR 820.150.iii. You did not have documentation to establish requirements for Distribution of your devices, per 21 CFR 820.160.iv. You did not have documentation to establish requirements for Installation of your devices, per 21 CFR 820.170.

l) Subpart M – Records. Specifically:i. You did not have documentation to establish General Requirements for Records, per 21 CFR 820.180.ii. You did not have documentation to establish Device Master Records, per 21 CFR 820.181.iii. You did not have documentation to establish procedures for Device History Records, per 21 CFR 820.184.iv. You did not have documentation to establish procedures for Quality System Records, per 21 CFR 820.186.v. You did not have documentation to establish procedures for handling Complaint Files, per 21 CFR 820.198.

m) Subpart N – Servicing. Specifically, you did not have documentation to establish requirements for Servicing of your devices, per 21 CFR 820.200.n) Subpart O – Statistical Techniques. Specifically, you did not have documentation to establish procedures for identifying valid Statistical Techniques, per 21 CFR 820.250.

The adequacy of your firm’s response cannot be determined at this time.

In the response, your firm provided 1) Corrective and Preventive Action (CAPA) Request 2025-04-09.01 US; 2) CAPA Request 2025-04-09.02 US; 3) CAPA Request 2025-04-09.05 US; and 4) CAPA FDA- Plan 2025-04-30 LEVO AG. Each CAPA noted that a specific Quality System requirement such as complaint handling and training would be addressed. Per CAPA Request 2025-04-09.01 US, your firm stated that the export of these medical devices to the U.S. are temporarily suspended until the action plan has been submitted to the U.S. FDA. Per CAPA FDA-Plan 2025-04-30 LEVO AG, your firm provided an outline of its corrective action plan and a timeline when these corrective actions will be completed.

To address this Quality System violation, 1) the documentation that addresses the requirements of 21 CFR 820, Quality System, should be provided for review and 2) the training records on the Quality System requirements should be provided for review. Without this documentation and the evidence of implementation that all regulatory requirements have been met, the adequacy of this response cannot be determined at this time.

Our inspection also revealed that your firm’s devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:

2. Failure to adequately develop, maintain, and implement written Medical Device Reporting procedures, as required by 21 CFR 803.17.

For example: Your firm has not developed, maintained, and implemented Medical Device Reporting procedures that address the requirements of 21 CFR Part 803 — Medical Device Reporting (MDR).

The adequacy of your firm’s response cannot be determined at this time.

In the response, your firm provided 1) CAPA Request 2025-04-09.03 US and 2) CAPA FDA-Plan 2025-04-30 LEVO AG. Per CAPA Request 2025-04-09.03 US, your firm stated that it will establish a Complaint Reporting System that will align with the requirements of 21 Part 803 and implement a training program based on these requirements. Per CAPA FDA-Plan 2025-04-30 LEVO AG, your firm provided an outline of its corrective action plan and a timeline when these corrective actions will be completed.

To address this requirement, 1) documentation that demonstrates the establishment of a complaint reporting system should be provided for review; 2) a retrospective review of any oral or written complaints using this newly created complaint reporting system should have been conducted; 3) copies of any completed MDR reports should be provided for review; and 4) the training records on the complaint reporting system should be provided for review. Without this documentation and the evidence of implementation that all regulatory requirements for complaint reporting and MDR have been met, the adequacy of this response cannot be determined at this time.

Our inspection also revealed that your firm’s devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information regarding the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:

3. Failure to ensure that the labeler of a device provide the information required by the subpart for each version or model required to bear a unique device identifier, as required by 21 CFR 830.300.

For example: Your firm has not submitted electronically to the U.S. FDA's Global Unique Device Identification Database (GUDID), the information required by 21 CFR Part 830, Subpart E, for each version or model required to bear a unique device identifier (UDI), for the Class II Standup Wheelchairs, manufactured by your firm and exported to the U.S.

The adequacy of your firm’s response cannot be determined at this time.

In the response, your firm provided 1) CAPA Request 2025-04-09.04 US and 2) CAPA FDA -Plan 2025-04-30 LEVO AG. Per CAPA Request 2025-04-09.04 US, your firm stated that it will establish a Device Identification System that will align with the requirements of 21 CFR Part 830 and implement a training program based on these requirements. Per CAPA FDA-Plan 2025-04-30 LEVO AG, your firm provided an outline of its corrective action plan and a timeline when these corrective actions will be completed.

To address this requirement, 1) documentation that demonstrates the establishment of a Device Identification System should be provided for review; 2) a retrospective review of the serial numbers of the medical devices that have been exported to the U.S. using the newly created Device Identification System should be provided for review; and 3) the training records on the Device Identification System should be provided for review. Without this documentation and the evidence of implementation that all regulatory requirements for the Device Identification System have been met, the adequacy of this response cannot be determined at this time.

Given the serious nature of the violations of the Act, LEVO C3; LEVO Combi; LEVO LAE; and LEVO LCEV, Class II Standup Wheelchairs, manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are addressed. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and address the violations described in this letter. We will notify you regarding the adequacy of your firm’s responses and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.

Other federal agencies may take your compliance with the FD&C Act and its implementing 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.

Your firm’s response should be sent by email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to Food and Drug Administration, Center for Devices and Radiological Health, Office of Regulatory Programs, Division of Regulatory Programs 2: Establishment Support, Regulatory Inspections and Audits Team, White Oak Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993. Refer to CMS Case 662165 when replying. If you have any questions about the contents of this letter, please contact: Heather Dean, Ph.D., at Heather.Dean@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 List of 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.