Inspections, Compliance, Enforcement, and Criminal Investigations
Access Point Medical LLC 22-Mar-07
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
|Kansas City District |
11630 West 80th Street
Lenexa, Kansas 66214-3340
March 22, 2007
RETURN RECEIPT REQUESTED
Ref: KAN 2007-04
Richard A. Davis, Vice President
Access Point Medical LLC
Three City Place Drive, Suite 750
St. Louis, MO 63141
Dear Mr. Davis:
During inspections of your firm located in St. Louis, Missouri, on August 29-31, 2006, and again on October 16-19, 2006 investigator(s) from the United States Food and Drug Administration (FDA) determined that your firm imports Rollator mechanical walkers and canes. 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 your Rollator mechanical walker and Offset Crook Canes 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 relevant to the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 C.F.R. Part 806--Reports of Corrections and Removals regulation . We received your response, dated December 11, 2006, 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. Significant deviations include, but are not limited to, the following:[redacted]
Failure to promptly report to FDA, within 10 working days, any correction or removal of a device to reduce a risk to health, as required by 21 C.F.R. 806.10(b). In June 2006, your firm initiated a field correction and removal related to reports that the fork on the wheel of Rollator mechanical walker was breaking; and, in March 2006, your firm initiated a field correction and removal of the canes after discovery the canes were made of unacceptable materials and could break. However, they were not reported to the FDA as required.
FDA has evaluated these two events and classified the correction and removal actions as Class II recalls. A Class II designation indicates that exposure to the violative product may cause temporary adverse health consequences. See 21 CFR 7.3(m). We have reviewed your response and have concluded that it is inadequate because, while the submission of this information to FDA is an adequate correction of the immediate problem, you have not made any indication that corrective actions have been initiated to ensure that corrections and removals that occur in the future will be reported within 10 days. Please provide documentation of any corrective and preventive actions initiated in response to these actions not being reported within 10 working days.
Our inspection also revealed that your Rollator mechanical walkers 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 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 develop, maintain, and implement written MDR procedures, as required by 21 C.F.R. 803.17, for the following:
(a) Internal systems that provide for:
(1) Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements;
(2) A standardized review process or procedure for determining when an event meets the criteria for reporting under this part; and
(3) Timely transmission of complete medical device reports to manufacturers or to us, or to both if required.
(b) Documentation and recordkeeping requirements for:
(1) Information that was evaluated to determine if an event was reportable;
(2) All medical device reports and information submitted to manufacturers and/or us;
(3) Any information that was evaluated for the purpose of preparing the submission of annual reports; and
(4) Systems that ensure access to information that facilitates timely follow-up and inspection by us.
Specifically, there are no MDR procedures, and subsequently, you did not conduct an investigation to determine whether complaints should be filed as a MDR.
We have reviewed your response, dated December 11, 2006, including the new procedures SOP015, Rev A, "MDR Reporting Procedure" and SOP014, Rev A, "Complaint Handling Procedure", which include new provisions for the timely identification, communication, and evaluation of complaints and other events that may be subject to MDR requirements, as well as requirements for timely reporting of that information in the event that they require reporting. The response also indicates that those complaints that had not been evaluated for MDR reportability have now been evaluated. Your response to this observation appears to be adequate.
Failure to submit a report to FDA, and a copy of this report to the manufacturer, as soon as practicable and no later than 30 calendar days after the day that you received or otherwise became aware of information from any source, including user facilities, individuals, or medical or scientific literature, whether published or unpublished, that reasonably suggests that one of your marketed devices may have caused or contributed to a death or serious injury, as required by 21 CFR Part 803.40(a), including but not limited to the following instances:
1 . Product complaint dated 4/3/06 for Heavy Duty Rollator, part #RL12010HD that reported a customer who resides in an assisted living facility, returned the Rollator to the shop because the seat was broken in half and stated he had been injured. The defective product may have contributed to a serious injury.
2. Product complaint dated 4/12/06 for Heavy Duty Rollator, part #RL12011 that reported a customer was using the Rollator and the wheel broke off causing the customer to fall. It further states the customer is going to have to be in a wheelchair for some time. The defective product may have contributed to a serious injury.
3. Product complaint 06-1667 dated 8/17/06 for Rollator, model #RL12010HD that reported on 8/5/06, the user injured his back when the caster broke on the Rollator. Access Point Medical received a call from the injured individual's daughter on 10/13/06 stating her father was hospitalized for a week as a result of the incident.
We have reviewed your response, dated December 11, 2006, and have concluded that it is inadequate because it does not make any indication that the events that should have been reported to FDA, with copies sent to the manufacturer, were submitted or provide any documentation that the device did not, or could not, have caused or contributed to a serious injury. While the new procedure SOP015 includes instructions for submitting MDR and Baseline reports, you must evaluate events that you are already aware of and report those events that require a MDR. Also we understand that your firm has decided to terminate its business relationship with the manufacturer of the devices, but please note that this does not relieve you of your responsibility to comply with FDA regulations, including 21 C.F.R. 803.40(a).
Failure to submit a report to the manufacturer, as soon as practicable and no later than 30 calendar days after the day that you received or otherwise became aware of information from any source, including user facilities, individuals, or through your own research, testing, evaluation, servicing, or maintenance of one of your devices, that one of the devices you market has malfunctioned and that this device or a similar device that you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur, as required by 21 CFR Part 803.40(b), including but not limited to the following instances:
1. Product complaint 06-1701 dated 9/1/06 for Rollator model RL1004A-RD that reported the, user fell straight back when the front left wheel broke off.
2. Product complaint 06-1670 dated 8/18/06 for Rollator Basic Firm Seat, model #RL10041 that reported the user fell and hit her head and bruised her buttocks when the brake did not hold.
3. Product complaint 06-1437 dated 6/23/06 for Heavy Duty Rollator, model #RL12010HD that reported the customer was walking with her Rollator down a ramp and fell down when the wheel cracked and snapped. She hit her left shoulder and was going to have an MRI to see if she tore her rotator cuff.
4. Product complaint 06-1423 dated 6/21/06 for Heavy Duty Rollator, model #RL12010 that reported the user fell and hurt her leg when the fork cracked but she did not want to go to the hospital.
We have reviewed your response, dated December 11, 2006, and have concluded that it is inadequate because it does not make any indication that the events that should have been reported to the manufacturer were submitted, or documentation that the malfunctions would not be likely to cause or contribute to a death or serious injury if they were to recur. While the new procedure SOP015 includes instructions for submitting MDR and Baseline reports, you must evaluate events that you are already aware of and report those events that require a MDR. Also we understand that your firm has decided to terminate its business relationship with the manufacturer of the devices, but please note that this does not relieve you of your responsibility to comply with FDA regulations, including 21 C.F.R. 803.40(b).
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) 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.
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 violation(s), or similar violation(s), 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 written response to this Warning Letter should be sent to Nadine Nanko Johnson, Compliance Officer at the above letterhead address.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) 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 violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
John W. Thorsky
Kansas City District