Inspections, Compliance, Enforcement, and Criminal Investigations
Eagle Parts and Products 14-Nov-08
Department of Health and Human Services
Public Health Service
Atlanta District Office
November 14, 2008
VIA FEDERAL EXPRESS
Frank Dolan, President
Eagle Parts and Products
1411 Marvin Griffin Rd.
Augusta, GA 30906
Dear Mr. Dolan:
During an inspection of your firm located at 1411 Marvin Griffin Rd., Augusta, GA 30906 on 9/15-16/08, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures powered 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. At the conclusion of the inspection, our investigator issued to you a Form FDA 483, List of Inspectional Observations. The violations noted during our inspection include, but are not limited to, the following:
1. Failure of management with executive responsibility to ensure that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization, as required by 21 CFR 820.20. Specifically,
a) Your quality policy and objectives were not established, defined, and documented.
b) You have not appointed a management representative to ensure that the quality system requirements are met, and to report to management on the performance of the quality system.
c) A quality plan was not established, defined, and documented.
This violation is a repeat one from our previous inspection of your facility on 6/26-28/06.
2. Procedures for conducting quality audits were not complete, as required by 21 CFR 820.22. Specifically your Quality Audit procedure, SOP-007, addresses only [(b)(4)] audits of Device History Records. This procedure does not specify how to conduct quality audits to ensure that your quality system is effective and meets the requirements of the Quality System Regulation. Your quality audit procedure specifies the review of only [(b)(4)] Device History Records per [(b)(4)] all other areas of the quality system are not being audited. Device History Records represent only a portion of the overall quality system.
This violation is a repeat one from our previous inspection.
3. Failure to document the disposition of non-conforming product, justification for use of nonconforming product, and the signature of the individual authorizing the use of nonconforming product, as required by 21 CFR 820.90(b). Specifically,
a) Non-conforming Material Report dated 9/12/06 documented welds on the anti-tip axle in the incorrect location. A notation was made to re-weld or to use them as-is. A notation was also made that the weld fixture was repaired, but there is no documentation to show if the non-conforming parts were re-welded or used.
b) Non-conforming Material Report dated 9/5/06 documented that the footrest was hitting the body of the chairs. A notation was made to change the dimensions of the footrest mount and to have the body supplier trim them for more clearance. There is no documentation to show that the footrest dimensions were changed or the body dimensions were changed. Additionally, there is no documentation to show that the affected parts were or were not used in the manufacture of wheelchairs.
c) Two different Non-Conforming Material Reports both dated 8/23/06 do not indicate that Quality Control approved the use of non-conforming components.
4. Failure to investigate the cause of nonconformities relating to the product, processes, and the quality system, as required by 21 CFR 820.100(a)(2). Specifically, the Medical Device Return Merchandise Authorization (RMA) Log documents that fifty-five RMA's have been issued between 10/4/07 and 9/10/08. Of these fifty-five, about 18 specify the reason for return as "warranty evaluation", 10 specify "will not charge". There is little or no documentation to show that the causes of these non-conformities were investigated.
5. Failure to evaluate whether a complaint represents an event that is required to be reported to FDA under Part 803 (Medical Device Reporting) of FDA's regulations; failure to properly review, evaluate and investigate complaints that involve the possible failure of a device; and/or failure to promptly review, evaluate and investigate complaints that represent an event which must be reported to FDA under Part 803, as required by 21 CFR 820.198. Specifically,
a) Incident Report (IR) 1002 dated 4/2/07 resulted from a report that the seat broke off of model 624-EZ powered wheelchair. The patient was not injured, but the malfunction could have resulted in patient injury. The investigation does not appear to be sufficiently thorough or adequate to meet the requirements of the regulation. This incident was not reported to FDA as an MDR reportable event.
b) Call list 10/2/06-10/6/06 (formerly used to document complaints) documents a call on 10/3/06 from a dealer who reported that a patient's powered wheelchair battery charger started smoking and caught fire. The patient was not injured, but the malfunction could have resulted in patient injury. There is no documentation to show that the incident was investigated. The incident was not reported to FDA as an MDR reportable event.
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 Serene N. Ackall, Compliance Officer at the address noted in the letterhead. If you have any questions about the content of this letter please contact Ms. Ackall at 404-253-1296.
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, issued to you 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.
Barbara A. Wood
Acting District Director