|Company:||Care Rehab and Orthopaedic Products, Inc.|
|Issuer:||Baltimore District Office|
|Issued:||April 22, 2008||Closed:||
Department of Health and Human Services
Public Health Service
Baltimore District Office
April 22, 2008
Via Certified Mail
Return Receipt Requested
Mr. Christian Hunt, President
Care Rehab and Orthopaedic Products, Inc.
7901 Jones Branch Drive, 6th Floor
McLean, VA 22102
Dear Mr. Hunt:
During an inspection of your firm located at 3930 Horseshoe Bend Road, Keysville, Virginia 23947, on December 5-7, 10-13 and 17, 2007 and January 10, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures electrodes and distributes various types of therapeutic and diagnostic products known as Care Select Stim, Care Select Stim Plus (with adapters and remote control use), Care Stim, Classic NMS, Care TENS, Classic TENS, Care IFC Plus, Care IFC Sport; Care ETS, and Care EMG. 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 Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of federal Regulations (CFR), Part 820. We received your response dated January 25, 2008 concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to [(b)(6)]. 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 of management with executive responsibility to appoint a member of management who shall have established authority over and responsibility for ensuring that quality system requirements are effectively established and effectively maintained as required by 21 CFR 820.20 (b)(3).
For example, there were no trained quality personnel on-site and no documentation to show that you have adequately implemented management review meetings and internal quality audit procedures.
We have reviewed your response and have concluded that it is inadequate because you did not provide information as to the qualification and training of your interim quality system managers or information on how you intend to train your internal audit teams and quality assurance unit.
2. Failure to review, evaluate, and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary, as required by 21 CFR 820.198(c).
For example, no follow-up investigation was conducted on complaints received regarding burns, shocks, or blisters after patients used your manufactured or distributed devices including Care TENS, IFC Sport, IFC Plus, Classic TENS SP, and electrodes.
We have reviewed your response and have concluded that it is inadequate because you have not explained the root cause for the devices causing the 'blisters' and the 'shocking symptoms.' You have not provided documentation to justify not submitting an MDR report concerning the blisters suffered by the patient and why the August 13, 2007 complaint remains open. Also, we request that you explain why the date of '4/4/2007' is documented in the record identified as 'Level 2' for device 'IFC-Plus CIFC110176.' Based on your written response, this record appears to document the 'Level 2' testing done in response to CCF-0001 092107-1 received by your firm on 9/21/2007. This date of testing precedes the date the complaint was received.
3. Failure to validate with a high degree of assurance, and approve according to established procedures, the results of a process that cannot be fully verified by subsequent inspection and test, and failure to document validation activities and results as required by 21 CFR 820.75(a).
For example, your firm Uses [(b)(4)] testing system software to perform output testing on incoming and returned finished devices, but structured validation of the output test and its software have not been performed.
We have reviewed your response and have concluded that it is inadequate because, although you have promised correction, you did not provide documentation of the validation of [(b)(4)] Medical Level 1 output testing.
4. Failure to implement and conduct quality 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, no quality audits have been conducted since 4/2005. Your QSOP #027 Internal Quality Audits states 'Customer Audits will be scheduled by the FDA Compliance Officer and will occur on an annual basis, unless otherwise required.'
We have reviewed your response and have concluded that it is inadequate because you did not provide information as to the qualification and training of your interim quality system, managers or information how you intend to train your internal audit teams and quality assurance unit.
5. Failure to hold devices prior to release for distribution until all the activities required in the Device Master Record are completed and the associated data and documentation is reviewed by designated individuals to assure the device meets acceptance criteria per established procedures as required by 21 CFR 820.80(d).
For example, electrode testing data was inadequate, number of electrodes required to he tested were not always tested, and units with values outside your firm's established failure level were released.
Your response to this observation appears to be adequate.
6. Failure to have documented evidence in the Design History File of the results of the design review, verification, validation, and transfer as required by 21 CFR 820.30 (e), (f), (g), and (h).
For example, no documentation could be produced to show that your firm had conducted a risk analysis, design planning, design review, design verification, and design transfer for the Class 2 electrodes.
We have reviewed your response and have concluded that it is inadequate because, although you have promised correction, you did not provide complete documentation showing compliance with design control requirements for your class II electrodes.
7. Failure to establish and maintain procedures to assure that equipment is routinely calibrated, inspected, checked, and maintained as required by 21 CUR 820.72(a).
For example, the impedance meter has not been calibrated since 12/27/01.
We have reviewed your response and have concluded that it is inadequate because, although you have promised correction you did not provide documentation of calibration of instruments such as the [(b)(4)] and the [(b)(4)] and related calibration SOPS.
Our inspection also revealed that your devices are misbranded under section 502(t)(2) of the Act, 352(t)(2), in that your firm failed or refused to furnish material or information, 21 U.S.C. 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:
8. Failure to submit an MDR within 30 days of receiving or otherwise becoming aware of information that reasonably suggested that a marketed device may have caused or contributed to a serious injury as required by 21 CFR 803.50(a)(1).
We have reviewed your response for the complaint dated 7/2007 and have concluded that it is inadequate because you have 30 days from receipt of any information that reasonably suggests that a reportable MDR event has occurred, to submit an MDR report to the FDA. Before the 30 day time frame has expired, the device manufacturer must determine whether the information it has received or become aware of reasonably suggests that a reportable MDR event has occurred and the event should be reported. In this case, the complaint dated 7/2007 and listed as part of Observation 2 on the FDA-483 indicated that the patient was "severely burned," which reasonably suggests a serious injury occurred. If your firm decides not to report an event, you must explain the justification for not reporting and file your documentation in the MDR event file. Your firm cannot wait past the 30 day timeframe until your investigation is complete to file a report. In this case, the follow-up information was received on 1/24/2008 which is past the 7/2007 injury report date by approximately six months.
9. Failure to forward to the agency reportable adverse event information that you had received involving a device that was/is not manufactured by or imported by your firm as required by 21 CFR 803.22(b)(2).
We have reviewed your response for the complaint dated 1/2007 and listed as part of Observation 2 on the FDA-483. You determined that the electrodes were the only component of the device in question that were manufactured by your firm. The device that the electrodes were connected to was manufactured by another company. Your investigation determined that the electrodes did not cause the injury to the patient. We have concluded that your response is inadequate because, although your investigation into the injury revealed that the electrodes that you manufactured did not cause the injury to the patient, you are required to forward information regarding the reportable event to FDA with a cover letter explaining that you did not manufacture or import the device that caused the injury.
10. Failure to document your decision not to file an MDR as required by 21 CFR 803.18(e).
We have reviewed your response for the complaint dated 2/2007 and listed as part of Observation 2 on the FDA-483. Your investigation into the injury revealed that the patient did not suffer a serious injury as first reported to your firm. You determined that, since an injury did not actually occur, you did not need to file an MDR with the agency. We have concluded that your response is inadequate because you made the decision not to file an MDR based on information received from the patient negating a claim of a serious injury, however you did not document this decision in your MDR event file.
11. Failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17.
For example, you do not address 30 Day Reporting Timeframes, MDR Five Day Reports, Baseline Reporting, and Supplemental MDR Reports in your MDR procedures. Also, you list and reference MDR requirements in your procedure, but you do not explain how you will apply the requirements in 21 CFR 803.17 to your unique products, processes, and complaints.
You did not address this in your response because it was not cited on the FDA-483, List of Inspectional Observations. FDA identified this deficiency during our review of your responses to Observation 2 and 3 on the FDA-483.
Additionally, the information documented in the e-mails provided in your response indicate that your devices may have been produced with defective lead wires. In light of this information, we ask you to provide responses to the following questions:
What you intend to do about devices produced with the apparently defective lead wires that caused patient [(b)(6)] burn?
What corrective measures have you taken regarding the defective lead wires? For example: Did you report the likely design flaw problem to the manufacturer of the lead wires, [(b)(4)] and, what instructions and training did you provide your employees to assure that none of the supposedly defective lead wires were used in the assembly of new finished devices?
We also request that you submit the modified QSOP's referenced in your written response to FDA-483 citation 2 which would provide the instructions for use by outside personnel to receive, and document injury related complaints.
A follow up inspection will determine that corrections are adequate.
You should take prompt action to correct the violations addressed in this letter for these devices or any other upgraded devices you may choose to design in the future or are currently designing. 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 deviation 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.
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 fifteen (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 the Food and Drug Administration, Baltimore District Office, Attention: Jose R. Hernandez, Compliance Officer at FDA, 2810 North Parham Road, Suite #160, Richmond, Virginia 23294.
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. If you have any further questions, please feel free to contact Mr. Hernandez at (804) 747-0124, extension 103.