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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Canon USA Inc 1/7/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone:    949-608-2900
FAX:    949-608-4415

WARNING LETTER

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

WL #14-13

January 7, 2013
 

Mr. Tsuneo Imai
Senior Director and General Manager
Canon USA, Inc.
15975 Alton Parkway
Irvine, CA 92618
 

Dear Mr. Imai:

During an inspection of your establishment located in Irvine, California, on June 12, 2012 - July 23, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm distributes digital radiology 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 to affect the structure or function of the body. Our inspection revealed that your Digital Radiography Sensor Panel devices are misbranded under section 502(t)(2) of the Act, 21 USC § 352 (t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by or under section 519 of the Act, 21 USC § 360i, and 21 CFR Part 803- Medical Device Reporting (MDR). Significant deviations include, but are not limited to:

1. Failure to report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets has malfunctioned and that this device or a similar device marketed by your firm would likely cause or contribute to a death or serious injury if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).

For example: the information included for MDR numbers 1000181430-2012-00010, 1000181430-2012-00016, 1000181430-2012-00011, 1000181430-2012-00017, 1000181430-2012-00004, and 1000181430-2012-00003 indicate that the devices (Digital Radiography CXDI-55G, CXDI-50C, and CXDI-70C) are associated with a recall resulting from a device malfunction. If a manufacturer takes or would be required to take an action under section 518 of the Act, 21 U.S.C. 360h, or 519(f) of the Act, 21 U.S.C. § 360i(f), as a result of a malfunction of the device or similar devices, then the malfunction is reportable. Reporters do not need to assess the likelihood that a malfunction will recur. The fact that the malfunction occurred once leads to the presumption that the malfunction will recur. Medical Devices; Medical Device User Facility and Manufacturer Reporting, Certification and Registration, Final Rule, 60 Fed. Reg. (December 11, 1995) 63585.

Your firm's responses to this observation dated August 6, 2012, October 4, 2012, and October 23, 2012 appear to be adequate. Your firm has established corrective actions to ensure timely reporting of MDRs.

2. Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17(a).

For example: after reviewing your firm's MDR procedure titled, "Medical Device Reporting," SOP M-1006, Rev. J, dated September 16, 2011, the following issues were noted:
 

a) Your firm's MDR procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example:
 

•  Your firm's procedure includes definitions from 21 CFR 803.3, but omits the definitions ·of the terms "reasonably known" and "reasonably suggests," found respectively in 21 CFR 803.50(b) and 803.20(c)(1).

•  The definition of the terms "becomes aware" and "malfunction" from your firm's procedure are not consistent with the definitions found in 21 CFR 803.3.
 

b) Your firm's MDR procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part. For example: there are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
 

c) Your firm's MDR procedure does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed: Instructions for how to obtain and complete the FDA 3500A form.
 

If your firm wishes to submit MDR reports via electronic submission it can follow the directions stated at the following URL: http://www.fda.gov/Forindustry/FDAeSubmitter/ucm107903.htm

If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the MDR Policy Branch at 301-796-6670 or by email at ReportabilityReviewTeam@fda.hhs.gov.

Our inspection also revealed that your firm's CXDI-550, CXDI-55C, and CXDI-70C devices 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 CFR Part 806 - Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:
 

1. Failure to submit a written report to FDA of a correction or removal of a device to reduce a risk to health posed by the device, as required by 21 CFR 806.10(a)(1).
 

For example:
 

a) Your firm initiated a field correction for the CXDI-550 and CXDI-55C solid state X-ray imaging devices for loose screws resulting in damaged circuit boards which caused image failures and repeat radiation exposures to patients with no resulting image. The correction was initiated to reduce the risk posed to patients from "excessive radiation exposure." This correction was not reported to FDA.
 

b) Your firm initiated a field correction for the CXDJ-70C solid state X-ray imager for loose screws resulting in damaged circuit boards which caused image failures and repeat radiation exposures to patients with no resulting image. The correction was initiated to reduce the risk posed to patients from "excessive radiation exposure." This correction was not reported to FDA. 

Your firm's response to this observation appears to be adequate.
 

2. Failure to keep records of corrections and removals not required to be reported to FDA under § 806.10, containing a justification for not reporting the correction or removal action to FDA, which shall contain conclusions and any follow-ups and be reviewed and evaluated by a designated person, as required by 21 CFR 806.20(b)(4).

For example: There is no documented rationale for not reporting to FDA the correction and removal conducted for the CXDI-70C solid state x-ray imager device.

Your firm's response to this observation appears to be adequate.

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 violations 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 business days from the date you receive this letter of the specific steps you have taken to correct the noted violations, as well as 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 you have taken. If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this WL.

Your response should be sent to:

Blake Bevill,
Director, Compliance Branch
Food and Drug Administration
1970 I Fairchild
Irvine, CA 92612-2506

If you have any questions about the content of this letter please contact Dr. Raymond W. Brullo, Compliance Officer, at (949) 608-2918.

If you wish to discuss MDR reportability criteria or to schedule further communications, you may contact the MDR Policy Branch at 301-796-6670 or by email at MDRPolicy@fda.hhs.gov.

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 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality management 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.
 

Sincerely,
/S/
Alonza E. Cruse
District Director
 

cc: Ms. Ingeborg Small
California Department of Public Health
Food and Drug Branch
PO Box 997435
1500 Capitol Avenue, MS-7602
Sacramento, CA 95899-7413