- Delivery Method:
- United Parcel Service
Mr. Hansjorg Reiner
- Alber GmbH
Vor dem Weisen Stein 12
72461 Albstadt Beden-Wurttemberg
- Issuing Office:
- Center for Devices and Radiological Health
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10903 New Hampshire Avenue
Silver Spring, MD 20993
SEPT 15, 2017
VIA UNITED PARCEL SERVICE
Mr. Hansjörg Reiner
Vor dem Weisen Stein 12
Albstadt Beden-Wurttemberg, Germany 72461
Dear Mr. Reiner:
During an inspection of your firm located in Albstadt Beden-Wurttemberg, Germany on May 8, 2017 through May 11, 2017, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures wheelchair power drive add-ons, including the Twion Power Push-Rim Power Drive System. 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 you dated May 29, 2017, 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 procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i).
For example, Document ID: 3260, Design Changes (Revision 26.0.1, dated 17.03.2017) indicates that the process goal is to ensure that design changes are “identified, documented, validated or verified, reviewed and approved for implementation” through the Engineering Change Control (ECN) process; however, software changes made to the smartphone application used to control the Cruise Mode for the Twion Power Add-on were not controlled through this process.
In addition, Test 363 – Test Designation: Drum (forward/reverse) and Drop Test , a test associated with ECN 16-00052, makes a “Normative Reference” to ISO 7176-8:1998, Requirements and test methods for static, impact, and fatigue strengths Part 10.4 – Two drum test and 10.5 – Drop Test. The test report indicates that a (b)(4) was tested. There is no documentation demonstrating that testing was completed in accordance to the standard during this design change.
This violation is a recurring observation from the previous inspection.
We reviewed your firm’s response dated May 29, 2017 and conclude that it is not adequate. Your firm opened CAPA #27736 to address the observation. Your firm indicates that it will analyze the suitability of the design change procedures for smartphone applications and medical device development in order to integrate them into one procedure, and plan to conduct training on the new procedure. Neither the new procedure, nor any training records were provided to support that these corrective actions have been completed. Your firm indicates that it will conduct an effectiveness check of the new design change procedure; however, your firm did not address any plans to conduct a retrospective analysis of other design changes to determine if there are other instances where design changes were not properly controlled.
With regard to the validation test method, your firm clarified that instead of executing 200,000 cycles in one direction in accordance with ISO 7176-8:1998, (b)(4). Your firm indicated that this was done due to the fact that every wheel can be switched from the left to the right side of the wheelchair, so one wheel is running forward and one wheel is running backwards in regards to the gear box. Your firm opened CAPA #27740 and stated that, for the validation of the design change under ECN 16-00052, you will carry out the two-drum test without any variations to ISO 7176-8.
Your firm also indicated that it will revise Document ID: 3260, Design Changes; however, the revisions you intend to make are not described. Your firm stated that it will conduct a review of similar increased/modified test methods and conduct retesting with variations to claimed standards if needed. Evidence that these corrective actions have been completed was not provided for review.
2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR 820.198(a). For example, seven of the twenty-three reviewed, closed complaints for the Twion power add-on did not include complaint investigations or documentation as to why an investigation was not conducted.
For example, Complaint #25584, “Customer says wheel keeps moving and [sic] he accidently hit a wall. No injuries”; however, no investigation as to what caused the wheel to keep moving was conducted. The complaint indicated that the root cause was user error and was subsequently closed.
The adequacy of your firm’s response dated May 29, 2017 cannot be determined at this time. Your firm opened CAPA #27748 and stated that it intends to analyze and revise Complaint Management Procedure, ID 10764 and any other connected procedures; however, the revisions your firm intends to make are not described. Your response indicates that your firm plans to analyze the interface of complaint handling with sale sites to ensure that all necessary investigation activities are adequately performed. Additionally, your firm indicates that it will analyze complaints of products handled by U.S. sales sites from the last three years and generate CAPAs and perform additional actions if needed. Evidence was not provided to demonstrate that these actions were completed.
3. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g).
For example, the Twion user manual entitled, twion MOBILITY PLUS PAKET (i.e., Section 3 of the user manual) indicates that “cruise control maintains the introduced speed as long as it is at least 1 km/h”. However, according to ID 3.98 in twion M24 Validation Report, Doc.-ID VA17-00366 VA 17-00379 (b)(4), the minimum speed for testing was (b)(4). There is no documentation to indicate that your firm tested the unit to ensure the twion cruise control is able to meet the 1 km/h minimum speed as documented in the User Manual.
We reviewed your firm’s response dated May 29, 2017 and conclude that it is not adequate. Your firm clarified that the lowest speed (1 km/h) represents the threshold speed when the cruise control mode starts to operate, and also the minimum speed to maintain the cruise control mode. Additionally, your firm stated that (b)(4) to 1 km/h. Though both speeds were validated, your firm stated that it only documented the first validation of the (b)(4).
Your firm opened CAPA #277746 to address this observation. Your firm indicated that it plans to revise Design Validation Procedure, Document ID 10806; however, the revisions your firm intends to make are not described. Evidence was not provided to demonstrate that these actions were completed nor has your firm provided evidence of the verification of effectiveness of the corrective actions.
With regard to twion M24 Validation Report, Doc.-ID VA17-00366 VA 17-00379 (b)(4), your firm stated that, from a risk standpoint, (b)(4)1 km/h version. During a teleconference held with your firm on July 19, 2017, your firm stated that it will repeat testing at 1 km/hour and will document validation activities in an updated design validation report; however, this document has not been provided for review. Additionally, your response is not adequate because your firm did not evaluate other design validations to determine whether there are other instances of inadequate or undocumented validation activities.
4. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
For example, your firm’s CAPA procedure, Dok.-ID: 12515, CAPA, rev: 1.0.1, dated 12.04.2017 states that “closure of a CAPA is generally done with the effectiveness check. An earlier closure, e.g. with implementation allowed by QM – if a rationale clearly shows that the measure evidently corrects the nonconforming issue.” However, three of seven CAPAs that included corrections or corrective actions that were reviewed lacked an effectiveness check to verify that the corrective/preventive actions were effective and did not adversely affect the finished device.
Additionally, (b)(4) used for testing validation for CAPA #25305; however, there is no documented justification of the adequacy of using (b)(4) for analysis.
We reviewed your firm’s response dated May 29, 2017 and conclude that the adequacy of the response cannot be determined at this time. Your firm opened CAPA #27741 to address the observation. Your firm indicated that it will revise the current CAPA procedure to indicate that effectiveness checks should be documented within the associated CAPA prior to closure. Your firm also indicated that it will review CAPAs from the last three years and will add documentation of effectiveness checks where appropriate. Evidence was not provided to demonstrate that these actions were completed.
Your firm clarified that the software change executed in CAPA (b)(4) was properly verified and validated during development and indicated that (b)(4) was used to confirm effective transfer of the software change; however, no documented justification of the adequacy of using (b)(4) was provided.
Your firm opened CAPA #27744 and indicated that the current CAPA procedure, as well as your Statistical Techniques Procedure (ID 11718), will be revised to require documentation of the applicable statistical sample size that is used; however, the revised procedures were not provided for review. Moreover, your firm indicated that it will conduct a review of CAPAs from the last three years and will add a rationale for the sample size chosen where appropriate; however, your firm did not indicate that these CAPAs will be reviewed for adequate effectiveness checks. Evidence was not provided to demonstrate that these actions were completed.
Given the serious nature of the violations of the Act, the Twion Power Push-Rim Power Drive System manufactured by your firm is 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 corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct 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.
Also, U.S. federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected.
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 correct 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 actions (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.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Inspections Support Branch, White Oak Building 66, Rm 3540, 10903 New Hampshire Ave., Silver Spring, MD 20993.Refer to CMS case #532755 when replying. If you have any questions about the contents of this letter, please contact: Matthew Krueger at (301) 796-5585.
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 the violations, and take prompt actions to correct the violations and bring the products into compliance.
CAPT Sean M. Boyd, MPH, USPHS
Deputy Director for Regulatory Affairs
Office of Compliance
Center for Devices and Radiological Health
Elijah N. Wreh
One Invacare Way
Elyria, OH 44035
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