Sedecal S.A.

During an inspection of your firm located in Madrid, Spain on January 20, 2025, through January 24, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures DX-D 100, DX-D 600, and MobileDiagnost wDR systems. 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. We received a response from Maria Luisa Gomez de Aguero, Director of Quality and Regulatory Affairs dated February 14, 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 21 CFR 820.100(a). Specifically, your firm initiated CAPA 20/028 to address customer complaints reporting DXD100 mobile x-ray units self-propelling crashing into x-ray control panel in one case and almost running into the patient, in the other case. This issue affects all mobile x-ray unit models. However, your firm failed to document an assessment of the risk of the affected units in the field for this issue, when investigating the cause of nonconformities relating to the product.

We reviewed your response and conclude that the adequacy of your firm’s response cannot be determined at this time. You stated that you will revise procedures PG-031 Customer complaint and PG-020 Risk management procedures to ensure that an investigation is documented properly. You also stated that you will revise procedure PG-019 Corrective and Preventive action and conduct training for the relevant personnel. Although your firm’s response states you will revise the relevant procedures, the revised procedures were not included in the response for evaluation. Your firm’s response does not include a retrospective review of related documentation to ensure compliance with the updated procedures and how these will be implemented moving forward. Documentation of corrective action, retrospective review as well as training is needed in order to adequately address this observation.

2. Failure to adequately establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). Design validation shall include risk analysis, where appropriate. Specifically, your firm conducted a recall to address unintended movement of MobileDiagnost wDR that could result in life threatening situations and cause the device to stop working as intended. However, the risk analysis for MobileDiagnost wDR (Document IH0532RA_Annex, dated April 26, 2022) fails to include this increased hazard severity (life threatening) to ensure that appropriate risk control measures are implemented.

We reviewed your response and conclude that the adequacy of your firm’s response cannot be determined at this time. Your response states that you will re-evaluate and document the risk analysis for the recall. You also state that you will revise procedures PG-031 Customer complaint and PG-020 Risk management procedures to account for risk analysis. Although your firm’s response states you will revise the relevant procedures, the revised procedures were not included in the response for evaluation. Your firm’s response does not include a retrospective review of related documentation to ensure compliance with the updated procedures and how these will be implemented moving forward. Documentation of corrective action, retrospective review as well as training is needed in order to adequately address this observation.

Our inspection also revealed that your firm’s DX-D100 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 806 – Medical Device; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:

3. Failure to submit a written report of a correction or removal of a device to FDA, initiated to reduce a risk to health or to remedy a violation which may present a risk to health, as required by 21 CFR 806.10. Specifically, your firm initiated CAPA 20/028 to address customer complaints reporting DXD100 mobile x-ray units self-propelling crashing into x-ray control panel in one case and almost running into the patient, in the other case. This issue affects all mobile x-ray unit models. Your firm implemented two corrective actions to address this issue and issued a service note to be distributed to customers. However, your firm failed to submit a report of correction or removal to FDA for these actions.

We reviewed your response to Observation 1 and conclude it is not adequate. Your investigation of the issue concluded that this issue does not pose a risk to safety due to the low speed of the movement and did not consider it as a reportable recall. However, your firm implemented two corrections to address this issue and issued a service note to be distributed to the customers. Our assessment concluded that the unintended movement presents a risk to health and your firm’s actions were initiated to reduce the risk to health.

Your firm’s devices are also electronic products subject to compliance with Subchapter C of the Act, Electronic Product Radiation Control, the requirements at 21 CFR 1000-1005, and the performance standards at 21 CFR 1020.30 and 1020.31. Your firm failed to comply with the regulations regarding reporting and recordkeeping.

4. Failure to conduct certification of an electronic product, based upon a testing program which is in accordance with good manufacturing practices, as required by 21 CFR 1002.30(a)(1). Specifically, a review of the design control records revealed that the wDR2.2 was approved and released for distribution in the US without documentation to show that the required performance standard checklist (Technical Report Subchapter J of 21 CFR MobileDiagnost wDR 2.2, Doc #R01005_21CKL) was completed to demonstrate compliance with the performance standard requirements prior to release of the product. The performance standard checklist was not completed until Jan. 14, 2025.

We reviewed your response and conclude that the adequacy of your firm’s response cannot be determined at this time. You stated that you will review and revise procedures PE-062 Design Verification, PG-044 Organization of Project Teams among others. Although your firm’s response states you will revise the relevant procedures, the revised procedures were not included in the response for evaluation. Your firm’s response does not include a retrospective review of related documentation to ensure compliance with the updated procedures. Documentation of corrective action, retrospective review as well as training is needed in order to adequately address this observation.

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 responses 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 CDRHWarningLetterResponses@fda.hhs.gov. Refer to CMS case 707156 when replying. If you have any questions about the contents of this letter, please contact: Lu Jiang at +1(240)402-5779.

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.