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  5. Wissner-Bosserhoff GmbH - 690242 - 08/30/2024
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WARNING LETTER

Wissner-Bosserhoff GmbH MARCS-CMS 690242 —

Product:
Medical Devices
Recipient:
Recipient Name
Mr. Thomas C. Erbsloeh
Recipient Title
CEO
Wissner-Bosserhoff GmbH

Hauptstraβe 4-6
58739 Wickede (Ruhr)
Germany

Issuing Office:
Center for Devices and Radiological Health

United States

August 30, 2024

WARNING LETTER
CMS# 690242

Dear Mr. Erbsloeh:

During an inspection of your firm located in Hauptstr. 4-6, North Rhine-Westphalia, Germany on April 22, 2024, through April 25, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures nursing beds to include the Sentida SC Nursing Bed. 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

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 Ilona Plum, Head of Quality Management & Regulatory Affairs, dated May 15, 2024, 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 ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results, as required by 21 CFR 820.72(a).

For example: Software validation activities and results for computer or automated data processing systems used as part of the quality system have not been documented.

Specifically, the (b)(4) Test Station, an electrical-function test, uses software (b)(4); however, the software was not affiliated with an equipment qualification report that includes a software validation report to ensure proper function of this quality control test tool. The (b)(4) Test Station is used as part of the final acceptance testing of electrical components for the nursing beds prior to the release for distribution.

Your response dated May 15, 2024, is not adequate. You implemented CAPA 2024_22 and determined the root cause for the lack of documented validation activities and results for software (b)(4) used in the (b)(4) Test Station as the lack of human resources in your Operations Department. Further, your response notes you had already identified deficiencies in your process validations in 2023, and as a result, formed the Operational Excellence Department on December 9, 2023, to perform all necessary validations. You prioritized process validations and had yet to get to the (b)(4) Test Station software. There was no evidence submitted to support your corrective and preventive measures, which were to have been completed by June 28, 2024. In addition, your response did not indicate whether you plan on conducting a retrospective review of all other test equipment to ensure it is suitable for its intended purposes and is capable of producing valid results.

2. Failure to adequately establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).

For example: Your CAPA procedure, VA-018, under section 5.1 notes that data on trends can be used to justify implementing corrective and preventive measures, as well as complaint/service records. A review of your service reports and complaints for 2023 and 2024 revealed a trend of problems related to electrical nonfunctional motor failures.

However, there was a failure to implement a CAPA for the complaints of motor failures associated with motor article (b)(4), as well as with motor article (b)(4).

Your response dated May 15, 2024, is not adequate. You implemented CAPA 2024_27 and determined the root cause of the problem as lack of knowledge of CAPA requirements and lack of training. As a result, corrective and preventive measures were identified to include, but not limited to, increased training for employees on the CAPA system, holding regular meetings to initiate and/or process CAPAs, and defining what constitutes the need to initiate a CAPA. There was no evidence submitted to support your corrective and preventive measures, which were to have been completed from May 3, 2024, to June 30, 2024. In addition, your response did not indicate whether you plan on conducting a retrospective review to determine if CAPAs should be initiated for other undetected failure mode trends, such as those from complaints, service issues or other quality data sources.

3. Failure to adequately establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a).

For example:

a. Your firm’s procedure for Supplier Qualification (VA17), under section 2.3, identifies qualification requirements to include contract agreement, maintenance of supplier audit report, and/or initial sampling, among other records, and identifies three categories of suppliers (e.g. Category 1, 2 and 3). However, the procedure does not define which supplier (Category 1, 2 or 3) should maintain the quality requirements described in the procedure.

b. A copy of your firm’s supplier questionnaire, Form FB 17-1, was not maintained for the suppliers of (b)(4) coating and metal framework that is required for the manufacturing of the nursing beds.

Your response dated May 15, 2024, is not adequate. You implemented CAPAs 2024_28 and 2024_29. CAPA 2024_29 revealed the main root cause for lack of adequate supplier qualification procedures was lack of knowledge. As a result, you proposed to revise your VA17, Supplier Management procedure, to include a new assignment matrix to show the supplier category in connection with specific requirements, such as “audit, contracts, etc.” Your response also states that your employees will be trained on the revised procedure, in addition to being trained on the international requirements for supplier management.

With respect to the lack of your supplier questionnaire, Form FB 17-1, for the suppliers of the (b)(4) coating and the metal framework, your response states that the supplier questionnaire is only for Category 1 and Category 2 suppliers and the (b)(4) coating supplier is a Category 3 supplier; therefore, the questionnaire was not completed for them. However, in response to the observation, you state that you are making an “exception” and will send the questionnaire to the Category 3 supplier by June 7, 2024. In addition, your response provides conflicting information regarding which category of suppliers are required to complete the questionnaire.

Your firm did not submit any documents to support your corrective and preventive measures, which were to have been completed from June 21, 2024, to July 31, 2024. Furthermore, the response did not indicate that you would review the qualifications of your suppliers to ensure the products or services provided conform to your specified requirements.

4. Failure to adequately establish and maintain design output procedures that contain or make reference to acceptance criteria and ensure that those design outputs that are essential for the proper functioning of the device are identified, as required by 21 CFR 820.30(d).

For example:

Your procedure for Design Output lacks the need to identify all essential output requirements for the release of the design project.

Your response dated May 15, 2024, is not adequate. You implemented CAPA 2024_25 and determined the root cause for the lack of identification of all essential output requirements in your procedure for Design Output was that your design process did not require that “design outputs” were harmonized with the instructions for use. This was attributed to a lack of knowledge by your personnel of the regulatory requirements for design controls. As a result, you revised your VA14 Development-Design Controls procedure to include that “(b)(4).” In addition, your response states that you will revise your VA10 Product Life Cycle procedure to reinforce the required essential design outputs. The VA14 and VA10 procedures were not submitted for review. There was no evidence submitted to support your corrective and preventive measures, which were to have been completed by June 30, 2024. In addition, you did not indicate whether you plan on conducting a retrospective review of other design projects to ensure that essential outputs were identified.

5. Failure to adequately establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b).

For example: As it relates to incoming receipt of motors, no test plan was created to provide a description of acceptance criteria or a sampling plan for release of motors under Article #01-012912, version 3 used in the production of Sentida SC Nursing Beds.

Your response dated May 15, 2024, is not adequate. You implemented CAPA 2024_26 to address this deviation. As a result, corrective measures were identified to include, but not limited to the following:

a. “Definition of the “target” process for incoming goods – in particular, the necessary adjustments in incoming goods are described, as well as the requirements for the inspection plans, especially with regard to the acceptance criteria and AQL sampling plan.”

b. “Documentation of the necessary adjustments in the incoming goods department in order to be able to adequately implement the procedural instructions for incoming goods.”

Your response refers to “procedural instructions,” but does not identify the instructions by name, nor were any procedures submitted for review. There was no evidence submitted to support your corrective and preventive measures, which have planned target completion dates from May 24, 2024, to February 28, 2025. Furthermore, your response did not indicate whether you would review all of your incoming acceptance activities to ensure that products received comply with your quality requirements.

6. Failure to adequately establish and maintain procedures to control all documents that are required by 21 CFR 820, as required by 21 CFR 820.40. For example: The Assembly Instructions, Document V065-01, for the Sentida SC nursing beds failed to include a reference to the drawing technical number and revision level to ensure employees are using the correct drawing when assembling the beds.

Your response dated May 15, 2024, is not adequate. You implemented CAPA 2024_23 and determined the root cause for the failure to include a reference to the drawing technical number and revision level in the assembly instructions as a “lack of evaluation of changes to technical drawings to determine whether the assembly instructions also need to be adapted as a result.” Your response states that the drawing number was to be added to the assembly instructions by July 31, 2024. There was no evidence submitted to support your corrective and preventive measures and the response did not mention adding the revision level to the assembly instructions. In addition, you did not indicate whether you plan on conducting a retrospective review of other instructions and documents to determine if they contain the correct drawing technical number and/or revision level.

7. Failure to adequately establish and maintain procedures to ensure that device history records (DHR) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part, as required by 21 CFR 820.184.

For example:

A copy of the assembly record, which documents the number of beds, accepted, rejected and/or reworked, was missing for 13 DHRs reviewed for the Sentida SC Nursing Beds.

Your response dated May 15, 2024, is not adequate. You implemented CAPA 2024_23 and determined the root cause for the incomplete device history records as lack of knowledge to document such data as the number of accepted, rejected and/or reworked devices. Your response contained proposed corrective measures; however, you did not provide evidence to evaluate the adequacy of your corrective measures. For example, “VA 23 Creation, Training and Documentation of Assembly Instructions” was not provided for review. Another proposed corrective measure is “Develop key figures for operations, in particular, the number of passed and failed tests, and the number of reworked beds.” There was no evidence submitted to support your corrective and preventive measures, which were to have been completed from June 30, 2024, to July 31, 2024. The response did not indicate whether you would review other DHRs to ensure completeness.

Corrections and Removals Regulation

Our inspection also revealed that your firm’s SafeControl handset 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:

Failure to keep a record of a correction or removal that contains information including a justification for not reporting the correction or removal action to FDA which shall contain conclusions and any follow-ups, and be reviewed and evaluated by a designated person, as required by 21 CFR Part 806.20(b)(4).

For example: Your firm conducted a corrective action related to the SafeControl handset device for the Sentida nursing beds.

Your response dated May 15, 2024, is not adequate. You determined, if the Sentida nursing bed is disconnected from power while in the “Locked” mode, when it is reconnected to power again, the mode resets to the “Resident” mode, allowing the patient access to adjust the position of the bed. The adjustability of the bed can lead to a hazard in certain care situations. You issued an Urgent Safety Information letter dated July 11, 2022, relating to the SafeControl handset, regarding supplementary information to the instructions for use for the nursing beds. Ultimately, a software update was implemented to set the handset to go back to the correct setting if disconnected. As such, new handsets were dispensed to customers. This action meets the definition of a medical device correction or removal initiated to remedy a violation which may present a risk to health, for which you are required to submit a Report of Correction or Removal to FDA. As of August 1, 2024, you did not submit a Medical Device Report of Correction or Removal to FDA for this action.

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 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, FDA Regulatory Inspections and Audits Team, White Oak Building 66, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS Case #690242 when replying. If you have any questions about the contents of this letter, please contact: David Wolloscheck, Ph.D. at 301-796-1480 or at David.Wolloscheck@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/

Kellie B. Kelm, Ph.D.
Acting Director
OHT 3: Office of Health Technology 3
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

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