Inspections, Compliance, Enforcement, and Criminal Investigations

CNMC Company, Inc. 6/20/14

  

Department of Health and Human Services logoDepartment 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 

 

June 20, 2014
 
WARNING LETTER NO. 2014-NOL-15
 
 
UNITED PARCEL SERVICE
Delivery Signature Requested
 
Krishnan Suthanthiran, President
Best Medical International, Inc.
7643 Fullerton Road
Springfield, Virginia 22153
 
Dear Mr. Suthanthiran:
 
During an inspection of CNMC Company, Inc., located at 865 Easthagen Drive, Nashville, Tennessee, on January 27-29, 31, and February 4, 2014, an investigator from the United States Food and Drug Administration (FDA) determined your firm manufactures radiologic quality assurance and accessories to linear accelerator devices.  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.
 
Our investigation revealed your Model 206 Dosimetry Electrometer, Water Phantom with depth Positioning Assembly, TheraPro, Model K602 Modified Keithley 602 Electrometer, Beam Sentry 2, Model 22 D Duel Diode Dosimeter, Model 10 Dosimeter/Electrometer, and Waterproofing Kits are adulterated under Section 501(f)(1)(B), [21 USC 351(f)(1)(B)], because you do not have an approved application for premarket approval (PMA) in effect pursuant to Section 515(a) of the Act, [21 USC 360e(a)], or an approved application for an investigational device exemption (IDE) under Section 520(g) of the Act, [21 USC 360j(g)]. These devices are misbranded under Section 502(o) the Act, [21 USC 352(o)], because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by Section 510(k) of the Act, [21 USC 360(k)]. For a device requiring PMA, the notification required by Section 510(k) of the Act, [21 USC 360(k)], is deemed satisfied when a PMA is pending before the agency. The kind of information you need to submit in order to obtain approval or clearance for your devices is described on the Internet at http://fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. FDA will evaluate the information you submit and decide whether your product may be legally marketed.
 
Finally, the investigation revealed your firm lacks registration and device listing. Therefore, devices manufactured or distributed by you are misbranded under Section 502(o) of the Act, [21 USC 352(o)], because the device was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under Section 510, 21 USC 360; was not included in a list, required by Section 510(j), 21 USC 360(j); and a notice or other information respecting the device was not provided to the FDA, as required by Section 510(k), [21 USC 360(k)].
 
This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC Section 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations, Part 820 (21 CFR 820).  We received your response letter written by Mr. Thomas M. Kraus, Vice President, CNMC Company, with enclosures, dated February 7, 2014, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, issued to him on February 4, 2014.   We address the responses below, in relation to each of the noted violations.  The violations include, but are not limited to, the following:
 
1.    Failure to ensure that all inspection, measuring, and test equipment is suitable for its intended purposes and is capable of producing valid results, as required by 21 CFR 820.72(a). For example, during the manufacture of Model 206 dosimeter/electrometer, serial number 11401356, you failed to document the serial number of the digital multimeter used to calibrate the device on January 23, 2014. Your procedure for calibrating dosimeters/electrometers directs the use of two digital multimeters, only one of which has been calibrated. In addition, during the manufacture of the TheraPro (9510), serial number 181, you failed to document the serial number of the digital volt meter/multimeter used to conduct leakage testing.
 
According to the written response from Mr. Kraus, you will review all work instructions and written standard operating procedures (SOP’s) for any needed changes or updates. You will also train your employees on all changed SOP’s and Work Instructions. You have not provided the revised SOP’s or Work Instructions.
 
2.    Failure to establish and maintain a design history file (DHF) for each type of device, as required by 21 CFR 820.30(j). For example, the design records for your TheraPro (9510), an accessory to a linear accelerator, does not include the following: a design or development plan; approved design inputs; documented or approved design outputs; documentation of design review meetings; or, documentation of design verification or validation activities.
 
According to the written response from Mr. Kraus, the original documentation will be retrieved and the proper forms for Design Input, Design Output, Design Review, Design Verification, Design Validation and Design Transfer will be completed. Although we agree you cannot create the design documentation to recreate the process; however, evaluating the current device to determine if it meets predetermined specifications may be acceptable. You have not provided any evidence demonstrating the currently marketed devices adequately meet the design specifications.
 
3.    Failure to maintain device master records for each medical device, as required by 21 CFR 820.181. Specifically, you fail to maintain device master records for the following: Model 10, dosimeter/electrometer; Model 22D, dual diode dosimeter; Model K602 Modified Keithley 602, electrometer; Model 105A Beam Sentry 1; and, TheraPro (9510), therapy beam and patient dose monitor.
 
According to the written response from Mr. Kraus, you believed the devices were Class 1 medical devices which are exempt from the requirement. You will create a device master record for future Class 2 medical devices. The above medical devices have been considered Class 2 medical devices which are not exempt from 21 CFR 820.
 
4.    Failure to sufficiently document the label and labeling used for each production unit, lot or batch in your device history records, as required by 21 CFR 820.120(d). For example, you failed to document labeling procedures or include copies of representative labeling in the device history record documenting the manufacture of the TheraPro, serial number 181.
 
According to the written response from Mr. Kraus, all documents that are supplied with CNMC manufactured product will be listed on the final traveler with their current revision and must be signed and dated by the person placing the document with the finished product. Although we agree with your intended corrective actions, you failed to explain if an SOP will be written to codify this procedure and training provided to employees.
 
You should take prompt action to correct the violations addressed in this letter for which you have not already provided an adequate response.  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.  Also, federal agencies are advised of the issuance of all warning letters about devices so 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 15 working days from the date you receive this letter of the specific steps you have taken to correct the noted violations for which you have not already provided an adequate response, including an explanation of how you plan to prevent these violations, or similar violations, from recurring.  Include documentation of the corrective action you have taken, such as your revised procedures.  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 Mr. Mark W. Rivero, Compliance Officer, at the above address.  If you have any questions about the content of this letter please contact Mr. Rivero at (504) 832-1290, extension 1103.
 
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 close out 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. 
 
Sincerely,
/S/                                                           
Thomas D. Clarida
Acting District Director
New Orleans District
 
 
cc: Thomas M. Kraus, Vice President
      CNMC Company
      865 Easthagen Drive
      Nashville, Tennessee 37217-1137

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