| Public Health Service Food and Drug Administration |
Waterview Corporate Center |
Department of Health and Human ServicesTelephone (973) 331-4906
April 14, 2011
UPS OVERNIGHT DELIVERY
WARNING LETTER
Michael J. Flowers
President & Chief Executive Officer
Electric Mobility Corporation
599 Mantua Boulevard
One Mobility Plaza
Sewell, NJ 08080
11-NWJ-15
Dear Mr. Flowers:
During an inspection of your firm located in Sewell, New Jersey on October 19, 2010 through November 16, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures and distributes electric scooters and powered wheel chairs. 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.
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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from Donna M. Huesken, Director of Quality and Regulatory, dated December 6, 2010, 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 establish and maintain adequate procedures for validating the device design, as required by 21 CFR 820.30(g).
For example: Design validation procedures associated with the We Go 250 power chairs did not include provisions to ensure device specifications conform with the needs and intended uses of the characterized user population. Design verification activities were conducted to demonstrate design outputs (e.g. specifications) met input requirements; however, no design validation confirming the specifications met the needs of persons with disabilities or their caregivers was conducted. A patient transfer lock was added to the We Go 250 power chair design as a result of a post-design transfer user observation that the We Go 250 can rotate during patient transfer from the chair making transfer difficult.
We reviewed your response and conclude that it is not adequate because although you have provided an updated Design Control procedure and a signed change control document, no documentation demonstrating corrected design validation of the We Go 250 power chairs was provided.
2. Failure to establish and maintain adequate 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:
a. Your firm's Design Controls procedure (PSOP-6, Revision 17), in effect at the initiation of this inspection, does not address how changes to the design are to be handled when they are made after design inputs have been approved but before the design is transferred into production.
b. Your firm's Design Controls procedure (PSOP-6, Revision 17), in effect at the initiation of this inspection, states that the Engineering Change Notice (ECN) process is used to make changes to the design of existing products. The ECN procedures and forms (PSOP-7, W0401002, W0301001, EMCEN_27), in effect at the initiation of this inspection, do not ensure design changes are validated or where appropriate verified before their implementation.
Your firm changed the design of the We Go power chair by adding a passenger transfer lock. The ECN Evaluation Form (T10118) associated with this change indicates that no verification or validation testing was needed and no documented rationale for this decision was provided.
Your firm issued an ECN (R9180) on July 7, 2009, which changed the revision of the controller software used in the 300B and 700B model scooters from revision #8 to revision #9. This change increased the motor resistance from (b)(4). There is no documentation to indicate that this change was validated/verified. According to your firm's engineer, the motor resistance affects the smoothness of the ride and scooter rollback.
We reviewed your response and conclude that it is not adequate because although you have provided updated Design Control procedures that include procedures for conducting appropriate design change, no evidence was provided to show that the concern documented in the observation was considered for application to other design changes that may not have been validated/verified.
3. Failure to review, evaluate, and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications as required by 21 CFR 820.198(c). This is a repeat deficiency from a previous inspection.
For example:
a. On August 23, 2010, a complaint (Problem Log Call #235251) about a scooter (S/N OZ950061) was received which states that the unit cuts out on the slightest bump. As of October 28, 2010, there was no record of any investigation into this complaint.
b. On May 4, 2010, a complaint (Problem Log Call #229930) about a scooter (S/N R6QR034482) was received which states that the unit is surging. As of October 28, 2010, there was no record of any investigation into this complaint.
c. On April 8, 2010, a complaint (Problem Log Call #231260) about a scooter (S/N R6QR035710) was received which states that there are seat problems. As of October 29, 2010, there was no record of any investigation into this complaint.
d. On October 5, 2010, a complaint (problem Log Call #236460) about a Model P326 power chair (S/N M100602142) was received which states that the seat base was loose on the seat post. Although records indicate that service tightened the seat base, there is no record of any investigation into why the seat base became loose.
We reviewed your response and conclude that it is not adequate because no actions are described to address previous complaints that do not have documented investigations. Additionally, no evidence has been provided to indicate that an updated procedure has been established.
4. 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:
a. Complaint Management procedure (QSOP-21) specifies that QA or a designee (i.e. Risk Management Consultant) shall review and evaluate all complaints to determine whether the event is reportable under 21 CFR 803. However, not all complaints are reviewed and evaluated for reportability by QA or a Risk Management Consultant (e.g. Problem Log Nos. 232808, 235105, 233102).
b. Complaint Management procedure (QSOP-21) does not contain provisions that specify when complaints will be investigated or that the results of investigations must be documented.
We reviewed your response and conclude that it is not adequate because no actions are described to address previous complaints that do not have documented reviews. Additionally, no evidence has been provided to indicate that an updated procedure has been established.
5. Failure to maintain a record, when no complaint investigation is made, that includes the reason no complaint 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: For complaint records where no investigation was marked as completed, the record did not include the reason no investigation was made and the name of the individual responsible for the decision not to investigate (Problem Log Call Nos. 235251, 229930, and 231260).
We reviewed your response and conclude that it is not adequate because, (1) documentation was not provided that describes why an investigation was not performed; and (2) documentation was not provided indicating the individual responsible for deciding not to investigate. Additionally, no updated complaint handling procedure and no documentation of the implementation and training regarding the new procedure was provided.
6. Failure to establish and maintain adequate procedures for acceptance of incoming product, as required by 21 CFR 820.80(b).
For example:
a. Your firm uses the visual, functional and programmer verification requirements identified in the Device Master Record (DMR) Acceptance Criteria document to perform receiving acceptance activities for the We Go power chairs. The DMR Acceptance Criteria for the We Go power chair states that functional testing includes a test drive but the document does not specify what constitutes a test drive (e.g., distance, direction, turns, and speed). This document also does not define acceptance criteria associated with the test drive (e.g., smoothness, noise, controlled motions);
b. There are no documented acceptance procedures associated with the Ultralite and LiteWay scooters.
We reviewed your response and conclude that it is not adequate because you have not provided a corrected incoming acceptance procedure or an evaluation of previous incoming acceptance activities to ensure that they did not result in acceptance of nonconforming product.
7. Failure to establish and maintain adequate procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages for the device’s design development, as required by 21 CFR 820.30(e)
For example: Although the design control procedure (Design Controls, PSOP-6) in effect at the time the We Go 250 power chair was being designed required reviews to be performed at various points during the design process, the design review done prior to release of the We Go 250 power chair was inadequate. A non-conformance report (NCR #01157) initiated on October 28, 2009, indicates that the We Go power chairs needed to be reworked to install a latch spacer. The design change validation corresponding to the non-conformance correction (CPAR #09015) was noted in the DHF as completed on November 19, 2009. However, a memo dated October 29, 2009, states that the final design reviews for these power chairs were successfully completed and that the We Go 250 was transferred into production, prior to validating and implementing the latch spacer correction.
The latch spacer prevents the latch lock from opening when no passenger is seated in the chair and it is driven over a bumpy area. If the latch lock opens, the power chair's frame sections can separate. No documentation was presented to demonstrate that the need to rework the We Go power chairs was considered during the final design review that transferred the design to production. Furthermore, on November 12, 2009, your firm received a complaint (problem Log Call #227544, Customer #066140) about a We Go power chair (S/N C90900018). This complaint states that on November 7, 2009, the latch lock on the customer's We Go malfunctioned.
We reviewed your response and conclude that it is not adequate because although you provided an updated Design Control procedure that includes procedures for design reviews and a signed change control document, no evidence of implementation and training was provided. Additionally, no documentation was provided indicating that a final design review leading to design transfer for the We Go 250 included the correction to the latch spacer nonconformance.
8. Failure to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation as required by 21 CFR 820.30(b).
For example: neither your firm's design plan (e.g., Project Tracking Matrix, Development Timeline) nor design control procedure (Design Controls, PSOP-6), in effect at the time the We Go 250 power chair was being designed, define responsibility for implementation of all of the design activities related to the We Go 250 power chair. The responsibility for performing the risk assessment, compiling the Device Master Record and performing verification/validation activities was not defined.
We reviewed your response and conclude that it is not adequate because no updated design plan with documented responsibilities for the We Go 250 power chair has been provided.
9. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, and to document this training, as required by 21 CFR 820.25(b).
For example: There is no documentation to demonstrate that three technicians (VS, 11 and OOC) who performed the latch lock rework of the We Go power chairs were trained on the rework instruction (WI 19259400) even though the Engineering Change Notice (ECN) associated with the rework states that training is required. Power chairs reworked by these technicians include S/Ns C90900004, C90900021, C90900037, C91200220, C91200237 and C91200239.
We reviewed your response and conclude that it is not adequate because you have not provided an updated training procedure or an evaluation of the previous training procedure to ensure that employees were trained to adequately perform their assigned responsibilities. Additionally, you have not provided evidence that your technicians have been trained on the rework instruction.
Our inspection also revealed that your Rascal AutoGo scooter (Model 600T) devices are misbranded within the meaning of 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 § 803 - Medical Device Reporting (MDR) regulation. These violations include, but are not limited to, the following:
1. Failure to report to FDA no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).
For example: Problem Log Number 235457, dated August 31, 2010, represents a serious injury that should have been reported to FDA. A broken wrist represents a permanent impairment of a body structure.
We have reviewed your response dated December 6, 2010 and have concluded that it is inadequate for the following reasons: (1) you have not submitted an MDR report for the above referenced complaint to FDA, and (2) you did not provide a copy of your revised MDR Procedure.
2. Failure to report to FDA no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market has malfunctioned and this device or a similar device that you market would be likely to contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).
For example: Problem Log Number 235258, dated August 23, 2010, states that a man fell to the floor after the seat on his scooter collapsed. There was no indication in the complaint that the man sustained an injury. Problem Log Number 232437, dated March 20, 2010, and Problem Log Number 229828, dated February 1, 2010, describe the seat lift’s master bolt breaking. All three events describe the same device malfunction that is identified in Recall #Z-0174/0175-2008 (posted November 21, 2007) as evidenced by the seat collapse and the bolt breaks.
Since the recall affects the Rascal brand 600T series scooter device, and those device malfunction complaints occurred after the date of the recall, a device malfunction associated with the problem identified in the recall would be reportable under 21 CFR §803. According to the Preamble, Page 63585, Comment 12, "Reporters do not need to assess the likelihood that a malfunction will recur. The fact that the malfunction occurred once leads to the presumption that the malfunction will recur. A malfunction is reportable if the manufacturer takes or would be required to take an action under sections 518 or 519(f) of the act as a result of the malfunction of the device or other similar devices."
Therefore, the events represent reportable device malfunctions under 21 CFR§803.50(a)(2).
We have reviewed your response dated December 6, 2010 and have concluded that it is inadequate for the following reasons: (1) you have not submitted the MDR reports for the above referenced complaints to FDA, and (2) you did not provide a copy of your revised MDR Procedure.
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 FDA 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 deviations 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.
We are requesting that you submit to this office on the schedule below, certification by an outside expert consultant that he/she has conducted an audit of your establishment's manufacturing and quality assurance systems relative to the requirements of the device QS regulation (21 CFR, Part 820). You should also submit a copy of the consultant's report, and certification by your establishment's Chief Executive Officer (if other than yourself) that he or she has reviewed the consultant's report and that your establishment has initiated or completed all corrections called for in the report. The initial certifications of audit and corrections and subsequent certifications of updated audits and corrections (if required) should be submitted to this office by the following dates:
• Initial certifications by consultant and establishment – September 15, 2011
• Subsequent certifications – September 15, 2012, and September 15, 2013
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Robert J. Maffei, Compliance Officer, U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey, 07054. If you have any questions about the content of this letter, please contact Mr. Maffei at 973-331-4906.
Finally, 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.
Sincerely yours,
/s/
Diana Amador-Toro
District Director
New Jersey District Office
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