Inspections, Compliance, Enforcement, and Criminal Investigations
The Standing Company
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit, MI 48207
August 20, 2010
David J. Maczik
President and Owner
The Standing Company
5848 Dixie Highway
Saginaw, MI 48601
Dear Mr. Maczik:
During an inspection of your firm located in Saginaw, MI on May 5-20, 2010, 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 Wheelchair. 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 human body.
The inspection revealed that these devices are adulterated within the meaning of section 501 (h) of the Act (21 U.S.C. § 35 1(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage or installation arc 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. These violations include, but are not limited to, the following:
1. Failure to establish and maintain a design history file for each type of device, as required by 21 CFR 820.30(j).
For example: Your design history file for the Powerstand Stand-up Wheelchair, model HPS-2 and PS-2 does not include a design and development plan; design inputs and outputs; design reviews; design verification and validation.
2. 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: You implemented on or around February 2009 a reclining back to the Superstand Stand-up Wheelchair, model SS-l and Powerstand Stand-up Wheelchair, model HPS-2 and PS2. The addition of the reclining back was not conducted according to a design change procedure.
3. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, and must include requirements for analyzing quality data to identify existing and potential causes of nonconforming product or other quality problems, using appropriate statistical methodology, where necessary, as required by 21 CFR 820.100 (a)(1).
For example: Quality data sources are not analyzed at regular intervals using statistical methodologies to identify existing and potential causes of nonconforming product or other quality problems which may require a corrective or preventive action.
4. Failure to establish and maintain a 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: There was no complaint form completed for complaint number CC09-0001 and CC10-0004 as per the Complaint Form Procedure (b)(4); an evaluation to determine if complaints require Medical Device Reporting (MDR) was not completed with MDR Decision Flowcharts for compliant numbers CC09-0001, CC09-002, CC09-003, and CC10-0004; and 22 out of 47 service log entries met the definition of a complaint but did not follow your firm's complaint handling procedures, "Customer Complaint" (b)(4).
5. Failure to establish and maintain procedures to ensure all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.
For example: You have not implemented the procedure "Purchasing Controls"(b)(4) and the Supplier Assessment Forms. The suppliers for the wheels used on the Superstand Stand-up Wheelchair; and brakes or joy stick controllers used on the Powerstand Stand-up Wheelchair have not been evaluated for their ability to meet specifications.
6. Failure to conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules, as required by 820.70(g)(2).
For example: Equipment was not inspected as per the dates specified on the "Equipment Maintenance List Schedule". Though the mill was required to be inspected (b)(4) and the next inspection date was documented as 4/13/2009 there was no documentation that the inspection was conducted.
7. Failure to establish adequate procedures for quality 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: Though the "Compliance Audit Guidelines (b)(4) state (b)(4). Your findings from the internal audits conducted February 12, 2009 and September 3, 2009 were not addressed as corrective actions.
8. Failure to ensure that management with executive responsibility review the suitability and effectiveness of the quality system at defined intervals, as required by 21 CFR 820.20(c).
For example: Though "Management Review" (b)(4) section (b)(4) requires management reviews to be held (b)(4) you have only conducted one (1) management review per year in 2008 and 2009.
We acknowledge the two written responses dated June 4, 2010 and July 12, 2010 made by your firm to address the deficiencies cited on the FDA 483, Inspectional Observations. We acknowledge that you have submitted the MDR to FDA for complaint CC08-001; the Customer Service Call Logs have been evaluated for complaints; trending of complaints has been completed; and equipment maintenance has been addressed. At this time we cannot fully evaluate the adequacy of your response because the submissions lacked sufficient detail and supporting documentation as you are still in the process of making corrective actions.
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.
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 at 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions about the content of this letter please contact Mrs. Quinlan at (313)393-8153 or by facsimile at (313)393-8139.
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 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.
Joann M. Givens
Detroit District Officer