Inspections, Compliance, Enforcement, and Criminal Investigations

Laser Engineering, Inc. 9/25/14

  

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 

 

September 25, 2014
 
WARNING LETTER NO 2014-NOL-21
 
UNITED PARCEL SERVICE
Delivery Signature Requested
 
Louis C. Wallace, President, CEO
Laser Engineering, Inc.
318 Seaboard Lane
Suite 101
Franklin, Tennessee 37067-8276
 
Dear Mr. Wallace:
 
During an inspection of your firm, located at 318 Seaboard Lane, Suite 101, Franklin, Tennessee, on March 26-28 and April 1 – 4, 2014, an investigator from the United States Food and Drug Administration (FDA) determined your firm manufactures surgical lasers.  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 are not in conformity with the 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 responses dated April 25, June 30, July 17, August 11, and September 15, 2014, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations, issued to you. We address these responses below in relation to each of the noted violations. These violations include, but are not limited to, the following:
 
1.    Failure to document the date and signature of the approving official of all documents, as required by 21 CFR 820.40(a). Specifically, none of the quality system procedures for controlling all phases of your medical device manufacturing operations have been approved by management.
 
We acknowledge you have appointed a Management Representative with authority and responsibility for ensuring the QMS requirements. We also acknowledge you will establish and implement new procedures; however, you failed to provide those procedures.
 
2.    You failed to review and evaluate complaints to determine whether an investigation is necessary, as required by 21 CFR 820.198(b). For example, the following service reports were not evaluated to determine if an investigation was needed: 
  • Service Report (b)(4), opened January 14, 2013, indicated in the "Complaint Information" section there was an unspecified failure "during set-up for procedure" and the case was rescheduled.  An internal Service Report stated an internal detector was replaced; however, no information was provided as to whether the detector replacement was a scheduled maintenance procedure or a component failure or who made the determination this report was not a complaint.
  • Service Report  (b)(4), opened May 20, 2013, was classified as a complaint which required repairs to a broken joystick and stated, "No 1/2 x 20 mounting "screw" in case?". No information concerning any investigation or determination of root cause was provided. The following forms were attached to this service report: (b)(4) and (b)(4) however, neither form was completed.
  • Service Report (b)(4) which was opened May 21, 2013, was classified as a complaint and identified components which needed repair. The service report noted the root cause was "Wear/Tear".  No documentation of any investigation was provided. The following forms were attached to this service report: (b)(4) and (b)(4) however, neither form was completed. 
We acknowledge you assigned a new Quality Assurance Technician to review all service reports weekly to determine if they should be classified as complaints. We also acknowledge you will schedule quarterly internal audits. You failed to address the service reports noted above.
 
3.    You failed to implement and record changes in methods and procedures needed to correct and prevent identified quality problems, as required by 21 CFR 820.100(a)(5). Specifically, you failed to conduct root cause analysis and document corrective actions resulting from an internal audit conducted April 27 and 28, 2009. In addition, you failed to evaluate two Medical Device Record (MDR) events for input into your Corrective and Preventive Action (CAPA) or a reason why a CAPA was not initiated.
 
You state that corrective actions to the deviations noted during the inspection will be eliminated by reorganizing your management team and revamping your standard operating procedures. We acknowledge you will review CAPA’s continually and audit them next year to assure compliance. You failed to address your methodology for conducting a root cause analysis or document the specific corrective actions resulting from previous internal audits.
 
4.    You failed to demonstrate the design of your Dual Switch (DS) optical switch on your MD 40/60/80 surgical laser was developed in accordance with an approved design plan and the requirements of 21 CFR 820.30(j). Specifically, your design history file for the MD 40/60/80 surgical laser fails to include design inputs, output, design review, design verification, design validation, design transfer, and design changes.
 
5.    You failed to include device specifications, production process specifications, quality assurance procedures in your device master records (DMR’s), as required by 21 CFR 820.181. Specifically, the Device History Record (DHR) for the Ultra MD laser system does not contain procedures for mounting the DS optical switch onto the laser tower, aligning and testing alignment of the optics, or acceptance criteria for evaluating the power output at the waveguide port.
 
We acknowledge the contract design and manufacturing facility for the Ultra MD laser will provide all design information to submit with the 510(k) supplement to FDA. You failed to provide your written standard operating procedures for device design controls.
 
6.    You failed to establish and maintain records of acceptable suppliers, contractors, and consultants, as required by 21 CFR 820.50(a)(3). Specifically, you failed to conduct vendor self-audits, site audits, vendor history or sample qualifications for any of your component suppliers.
 
We acknowledge you revised your Management Review and Internal Audit procedures. You failed to provide those procedures.
 
7.    You failed to include the date and signature of approval on your written standard operating procedures, as required by 21 CFR 820.40(a). Specifically, none of your written standard operating procedures have a signature of an individual approving the document.
 
8.    You failed to evaluate equipment which was not calibrated or take remedial action when it was not calibrated, as required by 21 CFR 820.72(b). Specifically, you failed to document the calibration of the (b)(4) which was out of specification since August 2012 and is used to perform in process and final power checks of your Ultra MD surgical lasers. In addition, (b)(4) has no calibration certificate.
 
We acknowledge you will calibrate and re-qualify all inspection and test equipment prior to the manufacture of future surgical laser products.
 
9.    You failed to remove obsolete documents from all points of use, as required by 21 CFR 820.40(a). Specifically, you recorded data on obsolete forms during Pot and Ground Test and the Laser Tube Processing which are contained in device history records for the Ultra MD surgical laser, serial number 615.
 
You failed to address the use of obsolete forms during tests procedures. 
 
10.    You released finished devices for distribution without the authorization by signature of a designated individual, as required by 21 CFR 820.80(d)(3). Specifically, the Quality Manager failed to review and sign the device history records for the Ultra MD, serial number 615.
 
11.    You failed to have quality audits conducted by individuals who do not have direct responsibility for the matters being audited, as required by 21 CFR 820.22. Specifically, you failed to conduct a quality audit since 2009.
 
We acknowledge your commitment for the Director of Quality Assurance to perform audits and will continue until all deficiencies and recidivist observations have been corrected. Further, we acknowledge that employee is scheduled to receive medical device training.
 
Additionally, our inspection revealed your firm’s Ultra MD 40/60/80 surgical lasers are noncompliant with Subchapter C, Electronic Product Radiation Control, Section 538(a) of the Act, 21 USC 360oo(a).  These violations include, but are not limited to, the following:
 
12.    Failure to provide a safety interlock for a portion of protective housing intended to be removable, as required by 21 CFR 1040.10(f)(2)(i).  For example, the fiber connector port in the new dual switch adaptor (DS Adaptor) accessory lacks safety interlock(s).  Additionally, the DHR for the Ultra MD 40, SN 615 did not contain any information pertaining to testing of an interlock for the DS Adaptor.  Further, Design records for the DS Adaptor did not contain any reference to the incorporation of an interlock to prevent unintended exposure to laser radiation greater than Class I.
 
We reviewed your firm’s response and conclude it is not adequate because the laser product report supplement, (b)(4) dated July 15, 2014, submitted to CDRH does not have information about safety interlocks required in the fiber optic connector port.  The product report supplement provides a description of the new DS Adaptor accessory, and a draft insert to the Operations, Maintenance and Instructions for Use manual, which will remain in draft form until your firm’s Special 510(k) is cleared.  However, the (b)(4) that bought the two units that incorporate the DS Adaptor were sent letters instructing them not to use them until your firm receives the 510(k) clearance and the hospitals receive updated operator’s manuals. Copies of the two notification letters were included in your firm’s response dated April 25, 2014.
 
13.    Failure to provide adequate instructions for assembly, operation, and maintenance, as required by 21 CFR 1040.10(h)(1)(i). For example, your firm had not created an updated operator’s manual that describes the new accessory, the DS Adaptor.
 
Your firm’s response to this observation appears to be adequate.  CDRH received the laser product report supplement, (b)(4) dated July 15, 2014.  The product report supplement provides a description of the new DS Adaptor accessory and a draft insert to the Operations, Maintenance and Instructions for Use manual.
 
14.    Failure to submit a supplemental product report prior to introduction into commerce, as required by 21 CFR 1002.11.  For example, CDRH had not received a supplemental laser product report at the time of the inspection demonstrating compliance to the laser product performance standard, 21 CFR 1040.10 and 11.
 
Your firm’s response to this observation appears to be adequate. CDRH received the laser product report supplement, (b)(4) dated July 15, 2014.
 
Our inspection also revealed your firm’s surgical lasers 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 regarding the devices required by or under Section 519 of the Act, 21 USC 360i, and 21 CFR 803 - Medical Device Reporting.  Significant deviations include, but are not limited to:
 
Failure to submit reports to the FDA no later than 30 calendar days after the day your firm received or otherwise became aware of information, from any source, that reasonably suggests a device that your firm markets has malfunctioned and this device or a similar device that it markets would be likely to 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:
  • On August 5, 2013, your firm became aware of an event involving an LEI ULTRA MD 60 in which the device malfunctioned during a procedure and was removed from the room where it began to smoke as if on fire and a fire extinguisher was sprayed into the vents. Your firm’s investigation could not determine the cause of the fire.
  • On November 12, 2013, your firm became aware of an event involving an LEI ULTRA MD 80 where the device was smoking during a procedure and was removed from the operating room.  Flames were seen inside the panel and a fire extinguisher was needed to extinguish the fire.
Your firm’s response dated April 25, 2014, to the FDA 483 appears to be adequate.  Your firm initiated a Corrective Action Request (CAR) titled: (b)(4) dated April 25, 2014, which indicates that MDRs for the referenced events were submitted to the FDA.  Copies of the reports were included as Attachments 3.a. and 3.b.  A copy of a certified mailing receipt, dated April 24, 2014, was also included in the attachments.  We do not have a record of having received the reports submitted on April 24, 2014.  However, copies of the reports included in Attachments 3.a. and 3.b. of your firm’s response were sent to our MDR Contractor for data entry.
 
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements:
 
 
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov.
 
 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 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.
 
We are requesting you submit to this office on the schedule below, certification by an outside expert consultant that he/she has conducted an audit of your establishment's manufacturing and quality assurance systems relative to the requirements of the device QS regulation (21 CFR, 820).  You should also submit a copy of the consultant's report, and certification by your establishment's Chief Executive Officer (if other than yourself) that he or she has reviewed the consultant's report and your establishment has initiated or completed all corrections called for in the report. The initial certifications of audit and corrections and subsequent certifications of updated audits and corrections (if required) should be submitted to this office by the following dates:
  • Initial certifications by consultant and establishment – March 1, 2015.
  • Subsequent certifications – Annually (by September 1, 2015, September 1, 2016 and September 1, 2017). 
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, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action (which must address systemic problems) 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 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 sent to: Mark W. Rivero, Compliance Officer, at the address above. If you have any questions about the contents of this letter, please contact: Mr. Rivero at (504) 832-1290, extension 1103.
 
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, 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 and to bring your products into compliance. 
 
 
Sincerely yours,
/S/                                                           
Kimberly L. McMillan
Acting District Director
New Orleans District

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