| Public Health Service Food and Drug Administration |
Baltimore District Office |
Department of Health and Human ServicesFEI: 3004987960
WARNING LETTER
CMS # 167912
March 8, 2011
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Dr. David B. Phillips, CEO
ReBuilder Medical, Inc.
636 Treeline Drive
Charles Town, WV 25414
Dear Dr. Phillips:
During an inspection of your firm located in Charles Town, West Virginia on January 4 and 11, 2011, investigator(s) from the United States Food and Drug Administration (FDA) determined that your firm manufactures the ReBuilderTM Transcutaneous Nerve Stimulator and the ReBuilderTM Bucket Transcutaneous Nerve Stimulator devices. 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 (C.F.R.), Part 820. We received your response dated January 24, 2011 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:
1. Failure to maintain procedures that address the identification, documentation, evaluation, segregation, and disposition of non-conforming product as required by 21 C.F.R. 820.90(a). Specifically, your complaint handling procedure dated August 2009 outlined how failed ReBuilderTM devices should be processed, investigated, analyzed and documented including how to prepare a written record of investigations. This procedure also discussed how failure investigations and analysis should be conducted and that returned product is subject to corrective action. However, the only records maintained for returned ReBuilderTM devices were the complaint logs which did not document the date the failed device was received by your firm, the failure investigation, the conclusion of the investigation and the disposition date.
Your 1/24/2011 response is inadequate as you failed to explain how your firm plans to ensure compliance with your revised device failure analysis procedure and how you plan to train employees on this procedure.
2. Failure to establish and maintain procedures for rework, to include retesting and re-evaluation of non-conforming product after rework to ensure that the product meets its current approved specifications as required by 21 CFR 820.90(b)(2). Specifically, your firm does not have a procedure in place for performing re-work activities on non-conforming signal generator components for the ReBuilderTM device. Your firm also does not maintain adequate records for the rework performed on the non-conforming signal generator components. The maintained records are marked with an (b)(4) which is placed in front of the serial number and do not document the problem or the corrective action taken. Between 10/25/2010 and 11/30/2010, 11.6% of the signal generator components used in your ReBuilderTM devices required re-work to correct a defect.
Your 1/24/2011 response is inadequate as you failed to explain how your firm plans to ensure compliance with your procedure for re-working non-conforming products and how your employees will be trained on the re-working procedure.
3. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA) for analyzing processes, work operations, quality audit reports, quality records, service records, complaints, returned product and other sources of quality data to identify existing and potential causes of non-conforming product or other quality problems and to employ appropriate statistical methodology where necessary to detect recurring quality problems, as required by 21 CFR 820.100(a)(1). Your firm was aware of the requirement to establish and maintain CAPA procedures. Specifically, your complaint handling procedure dated August 2009, discussed how the inclusion of a product which failed to meet specification in the manufacturer’s complaint file would help “assure compliance with 820.100” and included information on how to arrange compliant files to “facilitate detection of failure or defect trends.” The procedure further stated the requirements of 21 CFR 820.100 to be “identifying, recommending, or providing solutions for quality problems and verifying implementation of such solutions.”
Your firm failed to analyze customer complaints to identify and investigate the cause of non-conforming product. Your firm also failed to identify the cause of the non-conformity in 11.6% of the signal generator components used in your ReBuilderTM devices between 10/25/2010 and 11/30/2010.
Your 1/24/2011 response is inadequate as you failed to explain how your firm plans to ensure compliance with your CAPA procedures when you failed to identify and investigate the cause of the non-conforming product and returned product as outlined in your complaint procedure. Your response also stated that the President of your firm will review the complaint logs on a quarterly basis, however, you failed to state what training will be provided to your firm’s President to ensure that he is adequately trained to perform his assigned responsibilities. Your response also failed to state if you plan to perform any systemic corrective actions to ensure that all necessary data sources are appropriately analyzed and evaluated.
4. 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. Specifically, your firm stated in an untitled SOP dated 08/14/09 that your firm would “immediately develop internal quality audits of the firm’s processes. These processes will be in place within 30 days.” Your firm did not establish procedures for quality audits and has not conducted a quality audit since your firm began manufacturing the ReBuilderTM device in 2001.
Your firm released over (b)(4) finished ReBuilderTM devices for distribution between August 2009 and November 2010 without a record of the quality control acceptance testing activities such as the date of manufacture, the date of the acceptance testing; the equipment used to conduct the acceptance testing; and the signature of the individual performing the testing. A quality audit of your system would have identified that the device history records did not demonstrate that the ReBuilder devices were manufactured in accordance with the device master record.
Your 1/24/2011 response is inadequate as you failed to indicate how your firm plans to ensure compliance with the quality audit procedures and whether the independent auditor charged with conducting the quality audits will be an outside contractor or an employee of your firm.
5. Failure of management with executive responsibility 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 the requirements of 21 CFR Part 820 and the manufacturer’s established quality policy and objectives, as required by 21 CFR 820.20(c). Your firm was aware of the need to conduct audits as your complaint handling procedure dated August 2009 states that “activities of the unit (complaint-handling) should be assessed on a regular basis and corrections made if necessary.” Further, your firm stated in an untitled SOP dated 08/14/09 that your firm would “immediately develop internal quality audits of the firm’s processes.These processes will be in place within 30 days.” However, no management review has been conducted since your firm began manufacturing the ReBuilderTM device in 2001.
Your 1/24/2011 response is inadequate as you failed to indicate how your firm plans to ensure compliance with the conductance of management reviews. Your complaint handling procedure and undated procedure regarding quality audits in place at your firm since August 2009 required “regular or annual” reviews of these respective processes. However, your firm had no records to show that these audits had been performed.
6. Failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, as required by 21 CFR 820.50. For example, your firm has no written procedures to ensure that all purchased or otherwise received products and services conform to specified requirements for your ReBuilder devices. Your ReBuilder manufacturing procedure dated 10/19/09 outlined the criteria for accepting a new vendor. This procedure required the testing of a “product sample” from a vendor and if the “sample” passed the quality control criteria, the vendor would be approved. Your firm had no documentation pertaining to the qualification of your suppliers.
Also, the “Qualities and Specifications” procedure dated 10/12/09 states that the “President is empowered to note any patterns of poor quality and will use his personal judgment when considering re-orders from any manufacturer.” Between 10/25/2010 and 11/30/2010, 11.6% of the signal generator components used in your ReBuilder devices required re-work to correct a defect. The President of your firm performed the re-work on these non-conforming signal generators. However, your firm had no documentation to show that the supplier had been contacted to discuss the potential cause of the problem.
Your 1/24/2011 response is inadequate as you failed to indicate how your firm plans to ensure compliance with your purchasing procedures and supplier qualification. Your response also failed to include the training that will be provided to employees on your new procedure.
7. Failure to maintain adequate procedures to ensure the maintenance of adequate records of the investigation made under Section 820.198 by the formally designated unit, as required by 21 CFR 820.198(e). For example, the complaint unit employees at your firm do not follow your complaint handling procedure dated August 2009. The complaint procedure specifies that the complaint record include a sequential number; product information; who the complaint was assigned to; evaluation of complaint; results of evaluation; conclusions; notification and date of notification; final disposition; signatures and dates. A sample complaint record is included in the compliant handling procedure. This is a repeat observation from FDA’s 2009 inspection of your firm.
The complaint handling procedure dated August 2009 also required that “activities of the unit (complaint-handling) should be assessed on a regular basis and corrections made if necessary.” However, your firm had no records to show that these audits were conducted.
Your 1/24/2011 response is inadequate as you failed to indicate how your firm plans to ensure compliance with the new complaint handling procedure. Your response also failed to include the training that will be provided to employees on your new procedure and how often employee compliance to the new procedure will be evaluated.
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. 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 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.
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.
Your response should be sent to: U.S. Food and Drug Administration, Attention: Anne Aberdeen, Compliance Officer, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have questions regarding any issues in this letter, please contact Ms. Aberdeen at (410) 779-5134.
Sincerely,
/s/
Evelyn Bonnin
District Director
Baltimore District Office
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