| Public Health Service Food and Drug Administration |
| Detroit District 300 River Place Suite 5900 Detroit, MI 48207 Telephone: 313-393-8100 FAX: 313-393-8139 |
Department of Health and Human ServicesWARNING LETTER
2011-DET-04
November 9, 2010
VIA UPS EXPRESS
Mr. Dwight S. Gay
President and CEO
Gunnell, Inc.
8440 State Road
Millington, MI 48746-9445
Dear Mr. Gay:
During an inspection of your firm located in Millington, MI on June 7, 2010 through June 30, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the following wheelchair devices: Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Bariatric Rehab Tough and Tilt (TNT), Bariatric Rehab Recline and Mobility (RAM), Kidster, Rehab Multi-Adjustable Mobility (MAC), Flat Platform, and Positioning Platform. 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 all the wheelchair devices produced by your firm 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 devices are also misbranded under section 502(0) the Act, 21 U.S.C. 352(0), because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 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. 21 C.F.R. 807.81(b). 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.
This inspection also 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 (C.F.R.), Part 820. These violations include, but are not limited to, the following:
1. 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. No documented complaint procedure for receiving, reviewing, and evaluating complaints were established and no complaint file were available for review since complaints are not documented.
b. Return authorization forms were reviewed from July 4, 2008 to May 11, 2010. Of these, at least eight (8) returns met the definition of a complaint. You did not perform an investigation on these returns as to why there was the possible failure of your product to meet your wheelchair specifications.
2. Failure to establish and maintain adequate procedures for implementing corrective and preventative action as required by 21 CFR 820.100(a).
For example:
The "Corrective Action" and "Preventative Action" sections of your "Total Quality Management Process***with abbreviated descriptions" were not approved by management and in effect until June 2, 2010. Prior to this date, there was no approved documented procedure in place. Additionally, the Corrective Action and Preventative Action sections of the procedure are inadequate because it does not describe how quality data sources such as complaints, non-conformities, and service logs are to be analyzed at regular intervals using statistical methods to identify existing or potential problems.
3. Failure to establish and maintain adequate procedures to ensure that all purchased or otherwise received product and services conform to specified requirements as required by 21 CFR 820.50.
For example:
a. The "Purchasing" section of the "Total Quality Management Process***with abbreviated descriptions" were not approved by management and in effect until June 2, 2010. Prior to this date, there was no approved documented procedure in place.
b. Your management stated that there was no documentation of the evaluation of its supplier or an approved supplier list.
4. Failure to establish and maintain adequate procedures to ensure the device history records (DHR's) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part as required by 21 CFR 820.184.
For example:
a. There is no documented device history record (DHR) procedure which ensures that the DHR for each serial number is maintained to show that the device is manufactured in accordance with the device master record (DMR).
b. During the inspection forty-seven (47) serial numbers were selected for review. Thirty-seven (37) of the forms titled "Inspection Sheet" were missing. Twenty-five (25) of the forms titled "Order Sheet" were missing. Of the twenty-two (22) "Order Sheets" available for review, zero (0) were documented with the date the order was received for assembly and the name of the person completing the assembly. Nineteen (19) were incomplete for the date the order was received for shipping and the name of the person that shipped the finished mobility base wheelchair.
5. Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements as required by 21 CFR 820.90.
For example:
a. The "Control of Nonconforming Product" section of the "Total Quality Management Process***with abbreviated descriptions" were not approved by management and in effect until June 2, 2010. Prior to this date, there was no approved documented procedure in place.
b. Non-conforming parts were observed being stored in an unlabeled cardboard box in the wheelchair assembly area; and unlabeled wheels which had been returned, refurbished, or new were stored on the same rack.
6. Failure to establish and maintain adequate procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained as required by 21 CFR 820.72.
For example:
a. The "Control of Inspection, Measuring and Test Devices" section of the "Total Quality Management Process***with abbreviated descriptions" were not approved by management and in effect until June 2, 2010. Prior to this date, there was no approved documented procedure in place.
b. The digital calipers used for measuring incoming parts for correct dimensions were not calibrated and no documentation demonstrated that they had previously been calibrated. This was confirmed by management.
7. Failure to establish and maintain adequate 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:
a. The "Internal Audit" section of the "Total Quality Management Process***with abbreviated descriptions" were not approved by management and in effect until June 2, 2010. Prior to this date, there was no approved documented procedure in place.
b. There is no internal audit schedule or record of having conducted an internal audit within the last five (5) years.
8. Failure to establish and maintain adequate procedures to control all documents, as required by 21 CFR 820.40.
For example:
a. The "Change Control" section of the "Total Quality Management Process***with abbreviated descriptions" were not approved by management and in effect until June 2, 2010. Prior to this date, there was no approved documented procedure in place.
b. Documents used for assembly and inspection of the wheelchair devices did not include unique identifiers or revisions, such as "Receiving Inspection Checklist/Receiver," used to inspect incoming parts, "Inspection Sheet" used to inspect finish wheelchair models, "Assembly Instructions Manual" used to assemble the Rehab Tough and Tilt (TNT) wheelchair, "Base Frame" showing engineering prints of the Rehab Tough and Tilt (TNT) wheelchair, and "M.A.C.***Regular***Lower Frame" showing engineering prints of the Rehab Multi-Adjustable Mobility (MAC) Wheelchair.
9. Failure 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 21 CFR 820.20 and the manufacturer's established quality policy and objectives, and to document the dates and results of such quality system reviews, as required by 21 CFR 820.20(c).
For example:
a. The "Management Review" section of the "Total Quality Management Process***with abbreviated descriptions" were not approved by management and in effect until June 2, 2010. Prior to this date, there was no approved documented procedure in place.
b. There is no management review schedule or record of having conducted a management review within the last five (5) years.
10. Failure to establish and maintain adequate procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, and to document such training as required by 21 CFR 820.25(b).
For example:
The "Qualification Training" section of the "Total Quality Management Process***with abbreviated descriptions" were not approved by management and in effect until June 2, 2010. Prior to this date, there was no approved documented procedure in place. Additionally, the "Qualification Training" section is inadequate because it does not specify or define the "fundamental concepts of quality improvement" that the employees are required to be trained in.
Our inspection also revealed that your devices are misbra.nded 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 device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
Failure to establish and maintain procedures for the documentation and recordkeeping requirements for all Medical Device Reports and information submitted to FDA. For example, you do not have a documented procedure for evaluating and investigating complaints to determine how medical device reporting (MDR) to the Food and Drug Administration (FDA) is to be accomplished, as required by 21 CFR 803.17.
A follow up inspection will be required to assure that corrections are adequate.
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 Ms. 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.
Sincerely,
/S/
Joann M. Givens
Detroit District Director
Detroit District Office
Individual copy sent via UPS:
Dwight Steven Gay, Operations Manager
Gunnell, Inc.
8440 State Road
Millington, MI 48746
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