Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit, MI 48207
May 7, 2013
David J. Maczik
President and CEO
The Standing Company
5848 Dixie Highway
Saginaw, MI 48601-5967
Dear Mr. Maczik:
During an inspection of your firm located in Saginaw, Michigan on March 6, 2013 through March 27, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the manual Superstand Stand-Up Wheelchair and the half and full powered Powerstand Stand-Up Wheelchairs. 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 you dated April 16, 2013 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:
- Failure to establish and maintain complaint procedures that ensure complaints are effectively received, reviewed and evaluated by a formally designated unit, as required by 21 CFR 820.198(a). For example, Customer Complaint Forms (QP-0008-FM-1) have not been completed within 24 hours of learning that a complaint has occurred as per your firm’s complaint handling procedure “Customer Complaint”, QP-0008 (Rev. 2, effective date 6/9/2010). Your firm recorded numerous service calls from September 2, 2011 to March 5, 2013. Approximately 173 of the 228 entries on your service log meet the definition of a complaint according to 21 CFR 820.3(b). These complaints have not been investigated according to your complaint handling procedures.
The adequacy of your firm’s response cannot be determined at this time. You have indicated that you will be reviewing 173 of the complaints to determine which complaints, as per your SOP QP-0008 “Customer Complaint”, require a Complaint Form QP-0008-FM-01.
- Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). For example, your firm does not have a validated welding process. There are numerous aluminum or steel parts, sub-assemblies, or assemblies that are welded by your firm and used in the manufacturing of the manual Superstand Stand-up Wheelchair and the half and full powered Powerstand Stand-up Wheelchairs. These parts include the base assembly; armrest swivel sub-assembly; front and rear H-frame sub-assemblies; wrench lever; and upper raise lever sub-assembly. Your firm has received seven complaints between September 2, 2011 and March 5, 2013 on broken welds. Three broken welds were on the base frame.
The adequacy of your firm’s response cannot be determined at this time. You have indicated that you will be drafting a standard operating procedure (SOP) for welding operations and will conduct a validation and efficacy study to test the approved parameters.
- Failure to establish and maintain procedures to ensure all purchases or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example,
a. Your firm was unable to provide “Supplier Assessment” forms (QP-0011-FM-01) for (b)(4) suppliers as evidence that they have been evaluated in accordance with your procedure on “Purchasing Controls”, QP-0011 (Rev.1, effective 6/28/2010). For example, a supplier assessment form, for the supplier of front upright casting components, was not available. There have been two nonconforming material reports since 1/17/2013 for quality problems present in product purchases from this supplier.
b. According to your procedure “Purchasing Controls”, QP-0011 (Rev.1, effective 6/8/2010), a current list of all approved vendors shall be maintained (QP-0011-FM-03). The most current list available was last updated on June 8, 2010. Of the (b)(4) suppliers your firm is currently purchasing products or services from (b)(4) do not appear on the approved supplier list.
The adequacy of your firm’s response to observations 3a & 3b cannot be determined at this time. You have provided a revised Approved Supplier list dated 4/10/2013; revised SOP QP-0011 “Purchasing Controls” and the revised Supplier Assessment Form (QP-0011-FM-01). The completed Supplier Assessment Forms will need to be completed and submitted before an evaluation can be made.
c. Your SOP “Purchasing Controls”, QP-0011, (Rev.1, effective 6/8/2010), requires your firm to reevaluate suppliers on a (b)(4) basis. Your firm has not reevaluated any suppliers since September 5, 2010. For example, the supplier assessment form for the motor supplier indicates they were most recently reevaluated on September 5, 2010. Between September 2, 2011 and March 5, 2013, your firm has received 14 service calls, or complaints by definition of 21 CFR 820.3(b), of failing or malfunctioning motors.
We have reviewed your response and have concluded it is inadequate. Your response does not address the status of the supplier of motors which is classified as a class 1 supplier on your supply list. The class 1 supplier, as per your procedure, should be audited (b)(4). Your response does not address when you will start auditing your suppliers.
d. Your firm does not have in place any agreements requiring suppliers to notify your firm of changes in the product or service provided.
We have reviewed your response and concluded it is inadequate. Your revised Supplier Assessment Form, QP-0011-FM-01, does not address a supplier agreement to notify your firm of changes in the product or service at the time they occur.
- 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, your firm has made the following design changes:
The adequacy of your firm’s response cannot be determined at this time. You have submitted documentation for the redesign that you will include in the Design History Files and Design Master Files for the (b)(4). This information will have to be reviewed during the next inspection. You have also stated that you will be submitting Corrective Action and Preventive Action (CAPA) forms for the (b)(4) components within (b)(4)
According to your response, you plan to replace the (b)(4) for end users with wheelchairs that include this option. (b)(4). We want to remind you of your obligation to comply with 21 CFR 806, Medical Devices; Reports of Corrections and Removals.
Your response does not address how you will manage customers that have devices with the (b)(4), redesigned to (b)(4); and (b)(4) that were redesigned to increase the (b)(4).
- Failure to complete risk analysis, as required by 21 CFR 820.30(g). For example, your procedure on “Risk Analysis”, QP-0003 (Rev.0, effective 5/29/2008) has not been implemented. The procedure requires that all risks identified during final risk analysis with a risk score greater than (b)(4) be mitigated prior to commercial release of the device. The risk analysis for the Full Power Standing Wheelchair has risk scores greater than (b)(4) and no documentation that these risks have been mitigated.
The adequacy of your firm’s response cannot be determined at this time. You state a copy of the revised QP-0003 “Risk Assessment”, and Risk Analysis report will be provided in a later submission.
- Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example,
a. The procedure, “Nonconforming Product”, QP-0017 (Rev.0, effective 10/18/2010), requires nonconforming product records to be periodically reviewed and CAPAs initiated if trends are identified. Nonconforming data has not been analyzed to identify existing or potential causes of quality problems.
b. CAPAs initiated by your firm have not been verified as effective. CAPA #11-0001 was initiated in 2010 for nonconforming motors. The CAPA remains open and there have been 14 service calls between September 2, 2011 and March 5, 2013 on failing or malfunctioning motors.
CAPA #11-004 was initiated on August 15, 2011 after your firm identified a high incidence of service calls regarding broken flex shafts. The corrective action to redesign the flex shaft and flex shaft mount was implemented in September 2011. The CAPA remains opens. Between September 2, 2011 and March 5, 2013, your firm has received 6 service calls on the broken flex shafts with the “old” design.
The adequacy of your firm’s response cannot be determined at this time. Your response states that you have reviewed nonconforming product between September 2, 2011 and March 5, 2013. However, the review is on-going and CAPAs have been opened but were not included with the response.
- Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria as required by 21 CFR 820.80(d). For example, the procedure “Final Inspection”, QP-0022, (Rev. 1, effective 10/20/10), lists the Final Inspection Sign Off Sheet, QP-0022-FM-01 as an associated document. Neither the form nor the procedure explain how long the wheelchair must be driven, or activities to be performed during the Final Quality Check. The test acceptance criteria have not been specified.
The adequacy of your firm’s response cannot be determined at this time. You state a copy of the revised “Final Quality Check” will be provided in a later submission.
- Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, your firm has not maintained records of employee training since September 29, 2010. Your procedure on “Training Practices and Procedures”, QP-0028 (Rev.0, effective 7/7/2008) requires all (b)(4). Your firm has hired (b)(4) new employees since February 8, 2011, including the Plant Manager, who was designated on March 6, 2013 to also be your firm’s management representative.
The adequacy of your firm’s response cannot be determined at this time. In your response, you state that training will occur in phases, with the first phase being completed within 30 days.
- Failure to establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the quality system regulations, as required by 21 CFR 820.20(b). For example, your firm did not have a management representative from September 2011 to March 6, 2013.
Your response to this observation appears to be adequate.
- Failure to maintain adequate device master records, as required by 21 CFR 820.181. For example, the device master records for your manual, half-powered, and full-powered wheelchairs are incomplete because they do not include or refer to the location of production procedures. Your firm has not established procedures for the assembly of manual wheelchair (Model #SS-1) with folding frame; assembly of half-powered wheelchair (Model #HPS-2); assembly of full-powered wheelchair (Model #PS-2); and welding of the frame, and armrest assembly.
The adequacy of your firm’s response cannot be determined at this time. Your response references that three additional detailed assembly instructions will be completed in a long term project for the rest of the wheelchair models. The assembly instructions will be completed in 90 days.
- 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, as required by 21 CFR 820.22. For example, your firm’s procedure on “Compliance Audit Guidelines” QP-0027 (Rev. 1, effective 6/9/2010) requires audits to be performed (b)(4). Prior to the audit conducted on February 6, 2013, there were no audits conducted since February 8, 2011.
Additionally, the Compliance Audit Guideline requires CAPAs to be initiated based on the results of the quality audit, when such actions are “warranted”. The quality audit procedure does not include criteria to clearly define when opening a CAPA is necessary. There were no CAPAs opened at the close of your February 6, 2013 audit.
We have reviewed your response and determined it to be inadequate. Your response states a revision has been made to the Compliance Audit Guideline to initiate all CAPAs identified during the internal audit. The procedure does not expand on criteria to clearly define when to open a CAPA. Your response also does not address whether or not any CAPAs have been opened as a result of your February 6, 2013 quality audit.
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 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 for 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:
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 Catherine V. Quinlan, Compliance Officer, Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions about the contents of this letter please contact Ms. Quinlan at (313)393-8153.
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 close-out of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance 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.
Art O. Czabaniuk
Acting District Director
Detroit District Office