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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Dexta Corporation 6/25/14

  

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

Public Health Service
Food and Drug Administration
 San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94501 - 7070
Telephone (510) 337-6700 

WARNING LETTER

June 25, 2014
 
VIA UNITED PARCEL SERVICE
Signature required
 
Paul A. Rusin
President & CEO
Dexta Corporation
962 Kaiser Road
Napa, California 94558
 
Dear Mr. Rusin:
 
During an inspection of your firm located in Napa, California on March 4 through March 6, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that you manufacture medical chairs for use in Lasik surgery, dermatology & plastic surgery chairs, oral surgery, ophthalmology, orthodontics, and podiatry; surgical lights; and dental operative units.  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 any function of the body.
 
The 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. 
 
We received a response from Constantine James Nichols, General Manager, dated March 20, 2014, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm.  We address your response below, in relation to each of the noted violations.  These violations include, but are not limited to, the following:
 
1.    Failure to validate a process whose results cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a).
 
For example:  You failed to validate the automated manufacturing process of the elastic orthodontic bands.  You do not conduct quality checks on all of the bands manufactured.
 
The adequacy of your firm’s response cannot be determined at this time.  You did not include documentation of any corrections and only promise to make corrections by March 31, 2014.
 
2.    Failure to establish process control procedures that describe the controls necessary to ensure conformance to specifications where deviations from device specifications could occur as a result of the manufacturing process, as required by 21 CFR 820.70(a).
 
For example:  You manufacture latex orthodontic bands from natural materials using an automated extrusion and cutting process but do not have written procedures for setting manufacturing equipment parameters, quality control sampling and testing, or setting packaging and labeling equipment parameters.
 
The adequacy of your firm’s response cannot be determined at this time.  You did not include documentation of any corrections and only promise to make corrections by March 31, 2014.
 
3.    Failure to establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.
 
For example:  You have a list of current and former suppliers; however, when our investigator asked you for documentation of the approval and qualification of each supplier, your General Manager stated that you do not have that type of documentation.  The binder containing the list of suppliers does not have written specification or other quality requirements that each supplier must meet.
 
The adequacy of your firm’s response cannot be determined at this time.  You did not include documentation of any corrections and only promise to make corrections by March 31, 2014.
 
4.    Failure to establish and maintain procedures for acceptance activities, as required by 21 CFR 820.80(a).
 
For example:  You manufacture latex elastic bands for orthodontic use. However, your General Manager told our investigator that you do not have an incoming test or examination of the rubber latex material and have never conducted any testing of the raw material.
 
In addition, Ms. (b)(6) told our investigator that she conducts a stretch test on the orthodontic elastic bands.  She stated that the bands are supposed to stretch three times their original size; however, she was unable to provide a written procedure or explain the rational for the specification.
 
The adequacy of your firm’s response cannot be determined at this time.  You did not include documentation of any corrections and only promise to make corrections by March 31, 2014.
 
5.    Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100.
 
For example:  Your General Manager was unable to provide a copy of a corrective & preventive action written procedure.  Mr. Nichols told our investigator that he thought a former employee had created a procedure but he was unable to provide a copy.  Mr. Nichols has been employed by your firm for ten years and has occupied his current position for the past nine years.
 
The adequacy of your firm’s response cannot be determined at this time.  You did not include documentation of any corrections and only promise to make corrections by March 31, 2014.
 
6.    Failure to maintain complaint files and establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
 
For example:  Your General Manager was unable to provide a written procedure for receiving, reviewing, or evaluating complaints.  According to Ms. (b)(6), she is the person that would receive complaints, and she does not follow any written procedure.  She makes an undocumented determination of which complaints require escalation.  Any follow up or investigation that may occur is not documented and does not follow any written procedure.
 
The adequacy of your firm’s response cannot be determined at this time.  You did not include documentation of any corrections and only promise to make corrections by March 31, 2014.
 
7.    Failure to establish procedures for identifying training needs and ensuring that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b).
 
For example:  Your General Manager stated that you do not have training records or written procedures for identifying each employee’s training needs; your General Manager stated that you have no training records for the employees manufacturing the Mark 20x chairs, or the elastic bands; employee responsible for elastic band production was unable to answer questions about elastic band production. 
 
The adequacy of your firm’s response cannot be determined at this time.  You did not include documentation of any corrections and only promise to make corrections by March 31, 2014.
 
8.    Failure to establish procedures for conducting management reviews that assess the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency to ensure that the quality system satisfies the requirements of 21 CFR 820, as required by 21 CFR 820.20(c).
 
For example:  Your General Manager stated that you do not have written procedures in place to conduct management reviews and was unclear of what is required to be covered during management reviews.
 
The adequacy of your firm’s response cannot be determined at this time.  You did not include documentation of any corrections and only promise to make corrections by March 31, 2014.
 
9.    Failure to conduct quality audits and establish procedures for conducting quality audits, as required by 21 CFR 820.22.
 
For example:  Your General Manager stated that you do not have written audit procedures and was unable to provide documentation of any audits that may have been performed.
 
The adequacy of your firm’s response cannot be determined at this time.  You did not include documentation of any corrections and only promise to make corrections by March 31, 2014.
 
10.    Failure to establish and maintain procedures to adequately control environmental conditions that could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(c).
 
For example:  Printed circuit boards with sensitive electronic components are used in the production of the electronically controlled chairs, but your General Manager stated that you have no procedures for controlling or maintaining the electrostatic discharge area.
 
The adequacy of your firm’s response cannot be determined at this time.  You did not include documentation of any corrections and only promise to make corrections by March 31, 2014.
 
11.    Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).
 
For example:  Your General Manager stated that you do not document the non-conformance of in-process components, or finished products, any evaluations that may be conducted, re-work that may occur, or their disposition. Your General Manager confirmed that there are no written procedures for handling non-conforming components or finished products.
 
The adequacy of your firm’s response cannot be determined at this time.  You did not include documentation of any corrections and only promise to make corrections by March 31, 2014.
 
12.    Failure to establish and maintain procedures to control all documents that are required by 21 CFR 820, as required by 21 CFR 820.40.
 
For example:  Your General Manager was unable to provide a written document control procedure.  In addition, you have two documents titled, Q.A. Ortho/Exam Assembly Inspection Checklist, for use in the assembly of all Mark series chairs.  The two documents lack revision dates, document numbers or other identifiers to distinguish one from the other.
 
The adequacy of your firm’s response cannot be determined at this time.  You did not include documentation of any corrections and only promise to make corrections by March 31, 2014.
 
13.    Failure to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained, as required by 21 CFR 820.72(a).
 
For example:  Your General Manager was unable to provide calibration procedures for the scales, calibration weights, or grip hook weights.  In addition, you failed to calibrate the (b)(4) Sealer (P/N: 470000A15) used in the packaging of elastic bands, and the grip hook weights used in the quality control testing of elastic bands have not been calibrated since February 2002.
 
The adequacy of your firm’s response cannot be determined at this time.  You did not include documentation of any corrections and only promise to make corrections by March 31, 2014.
 
Our inspection also revealed that your firm’s Lasik surgery chairs, dermatology & plastic surgery chairs, oral surgery chairs, ophthalmology exam chairs, orthodontic exam chairs, podiatry exam chairs, surgical lights, and dental operative cabinets are misbranded within the meaning of section 502(o) of the Act, 21 U.S.C. § 352(o), in that the devices are not included in a list required by section 510(j) of the Act, 21 U.S.C. § 360 (j). 
 
In addition, it does not appear that your firm’s Mark chairs/tables are properly listed under the FRK product code. It is recommended that your firm contact our Division of Industry and Consumer Education (DICE) at e-mail DICE@fda.hh.gov or phone 1-800-638-2041 for assistance with determining the appropriate product code for your firm’s devices.
 
Your firm 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 civil money penalties.  Also, federal agencies may be advised of the issuance of 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 your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken.  If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
 
Your firm’s response should be sent to:  Lawton W. Lum, Director of Compliance Branch, 1431 Harbor Bay Parkway, Alameda, CA 94502. Refer to the Unique Identification Number CMS case #424400 when replying. If you have any questions about the contents of this letter, or would like to schedule a face to face meeting to present your corrections, please contact:  Sergio Chavez, Compliance Officer, at phone (510) 337-6886 or fax (510) 337-6703.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility.  It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.  The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.  Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
 
 
Sincerely yours,
/S/ 
Kathleen M. Lewis, J.D.
Director, San Francisco District