NAImco Inc dba Richmar Inc 12/30/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
December 30, 2011
WARNING LETTER NO. 2012-NOL-09
United Parcel Service
DELIVERY SIGNATURE REQUESTED
Robert J. Thompson
Chief Executive Officer
NAImco Inc., dba Rich–Mar, Inc.
4120 South Creek Road
Chattanooga, Tennessee 37406–1021
Dear Mr. Thompson:
On August 15 – 19 and 24, 2011, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, located at 4120 South Creek Road, Chattanooga, Tennessee, and determined your firm manufactures Ultrasound/Stimulator Electro-Therapy devices; Ionto+plus Electrode Drug Delivery Systems; Self Adhesive Electrodes; Lotion/Gel Warmer Units; Ultrasound Coupling Lotions; and Digital Moist Heat packs. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 United States Code (USC) 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 these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation do not conform with the Current Good Manufacturing Practice requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations, Part 820 (21 CFR 820). Our investigator’s observations, noted on the FORM FDA 483, Inspectional Observations (FDA 483), issued to you at the conclusion of our inspection, include, but are not limited to, the following:
1. Failure to review and evaluate all complaints to determine whether an investigation is necessary, as required by 21 CFR 820.198(b). For example, your firm did not review and evaluate the following complaints, or maintain a record which includes the reason no investigation was made, and the name of the individual responsible for the decision not to investigate:
a. Control ID number (b)(4) dated November 15, 2010, stated the device, “shocks people at the beginning of the treatment.”
b. Control ID number (b)(4) dated July 28, 2011, stated the device, “surges to point of pain experienced patient.”
c. Control ID number (b)(4) dated February 11, 2010, stated, “patient found burn mark apparent day after treatment-sending loaner-treat as incident.”
d. Control ID number (b)(4) dated January 21, 2010, indicates the device, “gives error code, freezes up and shocks patient only when turn off or remove leads/pads from patient.”
e. Control ID number (b)(4) dated December 27, 2010, stated the device is “shocking people.”
f. Control ID number (b)(4) dated July 29, 2010, stated the device “shocked someone and made them jump off the table.”
g. Control ID number (b)(4) dated June 15, 2011, stated the “(b)(4), stim is surging and shocking patients......clinic continued to use machine and a patient was burned.”
2. Failure to establish and maintain adequate procedures to ensure complaints are evaluated to determine if the complaints represent events which are required to be reported to FDA under 21 CFR part 803, Medical Device Reporting (MDR), as required by 21 CFR 820.198(a)(3). For example, your firm failed to evaluate the following complaints to determine if the events were MDR reportable:
a. Control ID number (b)(4) dated November 23, 2010, stated your firm's device, “shocks people badly-they scream-when using combo and profile.”
b. Control ID number (b)(4) dated August 23, 2010, stated your firm's device, “shocked (b)(4) people… in past (b)(4)”
c. Control ID number (b)(4) dated March 28, 2011, stated your firm's device, “shocked (b)(4) different patients.”
d. Control ID number (b)(4) dated September 21, 2010, stated they used your firm's device - on (b)(4) different people, (b)(4) connected to the stimulator at a high volt galvonic stem - which had electric surges, “when I hit the start button turning up the intensity of the unit, they both bolted up from the table because they were in tetanic contraction of their wrist flexors and extensor and bicep.”
e. Control ID number (b)(4)) dated October 1, 2010, stated they were using your firm's device when “multiple patients shocked near end of treatment.”
3. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example:
a. SOP-(b)(4) “Corrective Action” Rev (b)(4) does not adequately define:
i. The specific requirements and responsibilities for verifying or validating the corrective and preventive action to ensure such action is effective and does not adversely affect the finished device.
ii. Requirements or references to procedures which handle implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems.
iii. Any requirements to ensure information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems.
b. The effectiveness of CAPA number (b)(4), dated February 23, 2010, was not adequately verified. The CAPA was initiated because instructions on the production floor were being used without the appropriate approvals. The “Verification/Validation of Action Plan” section of the Corrective/Preventive Action form only states, “Properly formatted and approved verification activities were performed to verify the effectiveness of the changes and to ensure all documents were appropriately approved. In addition, the investigator observed a draft, unapproved version of work instructions titled, “Plug In Ultrasound Applicators Connector Assembly and Test DRAFT”, being used by employees during the manufacturing of electro-therapy devices.
4. Failure to establish and maintain adequate procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure the product meets its current approved specifications, as required by 21 CFR 820.90(b)(2).
For example, though SOP-(b)(4) “Nonconformity: Control, Review, and Disposition” Rev (b)(4) refers to rework and gives requirements for documenting disposition, your firm does not have any procedures for rework. In addition, SOP-(b)(4) states rework is to be documented in the (b)(4) Internal Failure database and a Concern Report printed and placed in the Device History Record. According to your firm, rework has been performed since February 2011, but manufacturing employees have not documented any nonconforming product being reworked or repaired since February 2011.
5. Failure to establish and maintain adequate procedures to ensure all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.
For example, SOP-(b)(4) “Supplier and Subcontractor Evaluation, Approval and Monitoring” Rev (b)(4) states a Vendor Survey Checklist is to be sent to new suppliers to evaluate the suppliers’ ability to conform to your firm’s specified requirements. At the time of the inspection, the survey had not been completed for (b)(4) supplier of circuit boards for your firm’s electro-therapy devices since February 2011. SOP-(b)(4) also requires your firm maintain an approved suppliers list, but your firm does not have an approved suppliers list.
6. Failure to establish and maintain adequate 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:
a. SOP-(b)(4) “Design and Engineering Changes” Rev (b)(4) states if a “software change affects the safety or effectiveness of the device, it must go through a full Software Verification and Validation prior to release to production. Otherwise, a limited Verification and Validation may be determined by the Engineering Manager and Regulatory Affairs Manager to be adequate.” Engineering Change Order (ECO) (b)(4), dated January 6, 2011, involves a change to the (b)(4) software, but your firm does not have any documentation of any software verification or validation activities associated with the change.
b. SOP-(b)(4) “Design and Engineering Changes” Rev (b)(4) indicates the Production Software List should include the most current version of the software approved for use and the revision date of approval, but the Production Software List does not include the revision dates of approval.
7. Failure to establish and maintain adequate acceptance procedures, where appropriate, to ensure specified requirements for in-process product are met, as required by 21 CFR 820.80(c).
For example, your firm began conducting a new (b)(4) test in response to multiple customer complaints regarding (b)(4) electrode devices. CAPA number (b)(4) describes the test as an in-process quality check, which includes manual testing of (b)(4) electrode assemblies per every (b)(4) assemblies, but your firm has not established any procedures for the test.
8. Failure to establish and maintain adequate procedures for acceptance of incoming product, as required by 21 CFR 820.80(b).
For example, WI-(b)(4) “General Receiving” Rev (b)(4) states “All items stay in the ‘Receiving Staging Area’ until released by Quality Assurance.” However, the Receiving Department was observed by the FDA investigator to be receiving components directly into stock by (b)(4) without waiting for Quality Assurance’s approval.
9. Failure to adequately document acceptance activities required under 21 CFR part 820.80, as required by 21 CFR 820.80(e).
Your firm does not document the date acceptance activities were completed and the specific testing equipment used to complete the testing. For example, “(b)(4) Functional Test Report” does not require documentation of the date the testing was completed or the equipment which was used.
10. Failure to maintain adequate Device History Records (DHRs), as required by 21 CFR 820.184.
For example, SOP-(b)(4) “Device History Record” Rev (b)(4) does not require the dates of manufacture and the primary identification label and labeling used for each production unit to be included in each DHR. None of the DHRs maintained by your firm include the dates of manufacture and the primary identification label and labeling used for each production unit.
11. Failure to maintain adequate device master records (DMRs), as required by 21 CFR 820.181. For example, the Device Master Record Index for the Thermasound 3 Series does not include the part numbers for the EVO Plug-n-Play devices.
12. Failure to establish adequate procedures for quality audits and conduct such audits to assure 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, on form "FCD-(b)(4), Internal Quality Audit Certification,” dated March 22, 2010, the auditors listed for the review of the Design Controls/Engineering Department included an employee who had direct responsibility for the audited department at the time the audit was completed.
Our inspection also revealed your firm’s devices are misbranded under Section 502(t)(2) of the Act, [21 USC 352(t)(2)], because your firm failed or refused to furnish material or information with respect to the device which is required by or under Section 519 of the Act, (21 USC 360i), and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:
1. Failure to adequately develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. For example:
a. SOP-(b)(4) “Regulatory Reporting” Rev (b)(4) does not establish a process which provides for:
i. Timely and effective identification, communication, and evaluation of events, which may be subject to MDR requirements. For example:
- SOP-(b)(4) only requires device failures which have caused or could lead to serious injuries are submitted to the Director of Regulatory Affairs for MDR consideration. Therefore, events, which occur because of user error or other reasons outside of a device malfunction or failure, might not be reported as MDRs.
- There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
ii. A standardized review process or procedures for determining when an event meets the criteria for reporting. For example:
- The definitions in SOP-(b)(4) are limited to “MDR Reportable event” and “Serious injury.” To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, the procedure should also include definitions from Part 803.3 for “Become aware,” and “Caused or contributed,” and definitions for “Reasonably known” found in Part 803.50(b),and “Reasonably suggests” found in Part 803.20(c)(1).
iii. Timely submission of complete medical device reports including:
- The circumstances under which your firm must submit a supplemental or follow-up report and the requirements for such reports.
b. SOP-(b)(4) “Regulatory Reporting” Rev (b)(4) does not describe how your firm will address documentation and record-keeping requirements. The procedure only states in section 6.5 that: “MDR complaints are maintained in perpetuity in a separate complaint file [in] the office of Regulatory Affairs,” which does not address the following:
i. Documentation of adverse event related information maintained as MDR event files;
ii. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable; and,
iii. A process to permit any authorized FDA employee to access records.
For your information, we also noted SOP-(b)(4) “Regulatory Reporting” Rev (b)(4) includes references to baseline reports. Baseline reports are no longer required and all references to a Baseline Report should be removed from your firm’s MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008).
Our inspection also revealed your firm’s single-use disposable electrode devices are misbranded under Section 502(t)(2) of the Act, [21 USC 352(t)(2)], because your firm failed or refused to furnish material or information respecting the device which is required by or under Section 519 of the Act, [21 USC 360i], and 21 CFR 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:
- Failure to submit a written report to FDA of any correction or removal of a device initiated by such manufacturer or importer when the correction or removal was initiated to reduce a risk to health posed by the device, as required by 21 CFR 806.10(a)(1).
For example: CAPA (b)(4), dated January 13, 2010, was initiated in response to multiple customer complaints regarding electrode terminal barrels for powered muscle stimulator devices not working appropriately, causing the lead wire to disconnect from the electrode. Your proposed corrective action stated customers were informed they might have received electrodes with defective terminal barrel crimps. The correction was initiated in response to a risk to health, because the disconnected electrodes result in an interruption of therapy. Therefore, your firm should have submitted a report to FDA regarding the correction.
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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Federal agencies are advised of the issuance of all warning letters regarding devices so they may take this information into account when considering the award of contracts. Additionally, premarket applications for Class III devices to which the QS 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 any additional, 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 corrections and/or corrective actions (including any systemic corrective actions) your firm has taken to include procedures, examples of DMRs and DHRs, complaint follow-up documentation, etc. If your firm’s 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 firm’s response should be comprehensive and address all violations included in this warning letter.
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 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 to bring your products into compliance.
Your response should be sent to Cynthia R. Gibson, Compliance Officer, U.S. Food and Drug Administration, at the above address. If you have any questions about the content of this letter, please contact Ms. Gibson at (251) 344-8208, extension 105.
Patricia K. Schafer
New Orleans District