| Public Health Service Food and Drug Administration |
| Kansas City District Southwest Region 11630 W. 80th Street Lenexa, Kansas 66214 Telephone: (913) 752-2100 |
Department of Health and Human Services
August 23, 2011
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
Ref: KAN 2011-14
Mr. Scott A. Zoetewey
President and Director of the Americas
ThyssenKrupp Access Corp.
4001 E 138th Street
Grandview, MO 64030
Dear Mr. Zoetewey:
During an inspection of your firm located in Grandview, Missouri, on February 24, 2011, through March 10, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the (b)(4), the Levant Patient Stair Lift, the Flow II, the (b)(4) stair lift, the (b)(4) stair lift, and the PL-S standard platform lift. 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 are intended to affect the structure or function of the body.
Our inspection revealed that the Flow II and Levant Patient Stair Lift devices are adulterated under section 501(f)(1)(B) of the Act, [21 U.S.C. 351(f)(1)(B)], because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, [21 U.S.C. 360e(a)], or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, [21 U.S.C. 360j(g)]. The Flow II and Levant Patient Stair Lift devices are also misbranded under section 502(o) of the Act, [21 U.S.C. 352(o)], because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by section 510(k), [21 U.S.C. 360(k)]. For a device requiring premarket approval, the notification required by section 510(k) of the Act, [21 U.S.C. 360(k)], is deemed satisfied when a PMA is pending before the agency. The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
Specifically, the inspection revealed that the Flow II and Levant Patient Stair Lift devices are not Non-AC-powered patient lifts but are powered patient transports. These devices differ significantly in design and technological characteristics from the (b)(4), (b)(4), (b)(4) and (b)(4) devices cleared under (b)(4). The (b)(4) model devices were cleared with the following specifications: (b)(4) powered, (b)(4) HP (b)(4) motor, (b)(4) feet per (b)(4) speed, (b)(4) controls and a (b)(4) drive system. The Flow II and Levant Patient Stair Lift devices are battery powered with a 24 V lead-acid battery, move at different speeds, are controlled wirelessly and by joystick and have a battery-driven drive system. The Flow II and Levant Patient Stair Lift devices have different drive systems, power systems, carrier rail designs, incorporate wireless control and gyroscopically controlled leveling in the Flow II, and other major technological differences as compared to the (b)(4) models. These differences affect your devices' capability to engage and disengage when commanded, whether your power source and radio controls can be interfered by or with other electronic
devices, and whether the battery adequately charges and operates safely.
This inspection also revealed that the (b)(4) stair lift, the (b)(4) stair lift, the PL-S standard platform lift, the (b)(4) stair lift, the Flow II, and the Levant Patient Stair Lift 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received a response (b)(6) from, Contract and Legal Administrator, dated March 28, 2011, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations, that was issued to you. 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 review, evaluate, and investigate complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications unless such investigation has already been performed for a similar complaint and another investigation is not necessary, as required by 21 CFR 820.198(c).
For example, on (b)(4), a voluntary MedWatch report was submitted to the FDA, alleging that your firm's (b)(4) stair lift had caught fire spontaneously while not in use. On October 12, 2010, FDA sent to you a copy of the voluntary MedWatch report and a request for additional information that you received on November 2, 2010. Management could not find any documentation of receiving or investigating this complaint.
We reviewed your firm's response and conclude that it is not adequate. Your firm did not identify the changes that will be made to the current complaint handling system to ensure compliance with this complaint handling requirement. Your firm stated that it will establish an electronic file for Investigation Reports and that the needs for this electronic file will be discussed with the firm's IT department. Your firm anticipated completion of this corrective action by (b)(4).
2. Failure to review and evaluate all complaints to determine whether an investigation is necessary and when no investigation is made, failure to maintain records that include the reason no investigation was made and the name of the individual responsible for the decision not to investigate, as required by 21 CFR 820.198(b).
For example, we reviewed the most recent 100 complaints received for the (b)(4) stair lift, the (b)(4) standard platform lift, and the (b)(4) stair lift, and none resulted in an investigation.
None of the complaint files reviewed contained a record of the decision not to investigate, the reason that an investigation was not conducted, or the individual responsible for making that decision, We reviewed your firm's response and conclude that it is not adequate. Your firm did not identify the changes that will be made to the current complaint handling system or how it intends to evaluate complaints to determine if an investigation is warranted.
3. Failure to establish and maintain procedures for receiving, reviewing and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
For example, your firm does not have a formally designated unit for receiving, reviewing, and evaluating complaints. Also, Section 5.10 of your firm's complaint handling procedure, Product Complaint Records (External Quality Reports-EQR 's Rev (b)(4)), states that complaints involving a serious injury or death, or the malfunction that could have led to such, will be filed according to SOP 5.1.1, FDA Medical Device Reporting. This procedure requires the use of (b)(4). However, management confirmed (b)(4), required by the procedure, are not currently used and have not been used in at
least one year.
We reviewed your firm's response and conclude that it is not adequate. Your firm did not identify the changes that will be made to the current complaint handling system. Your firm also did not address the failure to maintain complaint review procedures by a formally designated unit nor has your firm described how it intends to appoint a formally designated unit.
4. Failure to establish and maintain procedures for implementing corrective and preventive actions, and failure to document corrective and preventive action activities and their results, as required by 21 CFR 820.100.
For example, your procedure SOP 8.5.2 Corrective and Preventive Action (CAPA), requires your firm to enter internal Corrective Action Requests (CAR) into the database. Each approved CAR will be assigned a tracking number in the database. If the Corrective Action taken is deemed sufficient, your firm will update the CAR Tracking Database accordingly. Management confirmed that corrective actions have been performed at your firm. However, your firm failed to document corrective actions in the CAR Tracking Database and was unable to locate during this inspection any records of any corrective actions taken by your firm.
We reviewed your firm's response and conclude that it is not adequate. Your firm stated that it will be establishing and updating an electronic file for Corrective Action Requests. This file would include an index, list start and finish dates, and be easily accessed to provide information at any time. However, your firm has not described procedures to train the individuals from various departments, who are often involved in CAPAs and CAPA documentation, on this electronic file system. In addition, your firm has not provided any systemic corrective action to address this observation.
5. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Additionally, the training shall be documented, as required by 21 CFR 820.25(b).
For example, your firm failed to document training. FDA requested to review training records on February 24, 2011, February 25, 2011, and March 7, 2011. Your management was unable to locate or provide any training documentation. On March 19, 2011, your management confirmed that the firm currently has no procedure to identify training needs.
We reviewed your firm's response and conclude that it is not adequate. Your firm stated that it will hold training sessions on how to receive product complaints and training on medical device reports (MDRs). Your firm anticipated this training to be completed by (b)(4). You firm also planned to train new employees on this training within (b)(4) of employment and to add this requirement to the training schedule. Your firm did not address the lack of a training procedure and training records.
6. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. These quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited, as required by 21 CFR 820.22.
For example, your firm failed to conduct and document quality audits at scheduled intervals. The firm's procedure, SOP 8.2.2.1 Quality Management System (QMS) Review (Rev. (b)(4)), requires review of the quality management system by auditing each SOP at a minimum of (b)(4) and completion of a QMS Review Form. Your management confirmed that quality audits had not been formally conducted or documented for at least two years. Your management was unable to locate during the inspection any records of any quality audit.
We reviewed your firm's response and conclude that it is not adequate. Your firm has not described how you will review all procedures to ensure compliance with 21 CFR 820.22, nor described how the effectiveness of these procedures would be evaluated. Your firm planned to develop a (b)(4) schedule of Standard Operating Procedures to be reviewed. Your firm expected to hold a meeting on (b)(4), with the responsible parties to develop a schedule and method of documenting the reviews.
7. Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of 21 CFR Part 820 and the manufacturer's established quality policy and objectives, as required by 21 CFR 820.20(c).
For example, your firm has not conducted or documented Management Reviews since (b)(4). Your firm's procedure, SOP 5.6 Management Reviews (Rev. (b)(4)), requires that "(b)(4)"
We reviewed your firm's response and conclude that it is not adequate. Your firm stated that SOP 5.6 Management Review will be updated. Additionally, your firm stated that (b)(4) management review meetings will be conducted according to an "attached schedule," the first being held on (b)(4). However, your firm did not provide the stated "attached schedule," and it is unclear whether the corrective action has been implemented.
Our inspection also revealed that your 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 devices that is required by or under section 519 of the Act, [21 U.S.C. 360i], and 21 CFR Part 803 Medical Device Reporting (MDR) regulation. Significant violations include, but are not limited to, the following:
1. Failure to report to the FDA no later than 30 calendar days after the day you became aware of information that reasonably suggests that your device malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction was to recur, as required by 21 CFR 803.50(a)(2).
For example, you received a complaint regarding your (b)(4) Stair Lift catching fire spontaneously. On October 12, 2010, FDA sent to you a copy of the voluntary MedWatch report and a request for additional information that you received on November 2, 2010. To date, you have not reported this event to FDA.
2. Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. For example:
a. Your firm received a complaint regarding your (b)(4) Stair Lift catching fire spontaneously. On October 12, 2010, FDA sent to you a copy of the voluntary MedWatch report and a request for additional information that you received on November 2, 2010. There was no evidence or documentation that you evaluated this event to determine if it was reportable to FDA.
b. Your firm's MDR procedure does not indicate your responsibility to submit written MDRs on Form 3500A or an electronic equivalent, nor does it indicate the proper timeframes for reporting 30-day reports and 5-day reports.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all 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 violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
You should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality management systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions you have taken. If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these 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. Your response should be comprehensive and address all violations included in this Warning Letter.
Your firm's response should be sent to Patrick Wisor, Compliance Officer, U.S. Food and Drug Administration, Kansas City District Office, 11630 West 80th Street, Lenexa, Kansas, 66214.
Sincerely,
/S/
John W. Thorsky
District Director
Kansas City District Office
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