Inspections, Compliance, Enforcement, and Criminal Investigations

W & R Investments, LLC 8/5/16

  

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

Public Health Service
Food and Drug Administration
 
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556 

 

WARNING LETTER
CMS 495980
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
 
August 5, 2016
 
Louis Wallace
President and CEO
W&R Investments, LLC dba Laser Engineering
475 Metroplex Drive
Nashville, TN 37211
 
Dear Mr. Wallace:
 
During an inspection of your facility W & R Investments, LLC dba Laser Engineering located at 113 Cedar Street, Milford, MA from April 5 through 13, 2016, investigators from the United States Food and Drug Administration (FDA) determined that your firm is manufacturer of the UltraLaser Flexible CO2 Laser Waveguide, a Class 2 sterile medical device, indicated for use with CO2 laser systems for general and plastic surgery procedures. 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.
 
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 the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Parts 820. We acknowledge your April 28, 2016 response to the FDA 483. We have reviewed the response and have concluded that it is inadequate. We address your responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
 
1.    Failure to establish and maintain procedures for validating the device design as required in 21 CFR 820.30(g).
 
Specifically,
 
a)  There is no documentation of post-sterilization product performance testing for the UltraLaser Flexible CO2 Laser Waveguides, and
b)  Lot numbers of the hollow glass waveguides are not traceable to the UltraLaser Flexible CO2 Laser Waveguides used for the sterilization validation report dated February 2013. As a consequence, FDA investigators were unable to determine the fiber coating materials and processes used for the fibers used during your sterilization validation.
 
We have reviewed your response and have concluded that it is inadequate. You did not provide documentation of the testing procedures you are planning to put in place nor did you provide any documentation that the changes will be effective. A follow-up inspection will be required to assure that corrections are adequate.
 
2.    Failure to establish and maintain processes for verifying the device design. Design verification shall confirm that the design output meets the design input requirements, as required in 21 CFR 820.30(f).
 
For example, your waveguide design verification testing records were dated October 17, 2012, which is prior to the (b)(4) sterilization validation cycle performed on January 25-26, 2013.
 
We have reviewed your response and have concluded that it is inadequate. Please provide documentation to verify corrective actions have been made. A follow-up inspection will be required to assure that corrections are adequate.
 
3.    Failure to maintain device history records as required in 21 CFR 820.184.
 
Specifically, history records pertaining to the hollow glass waveguide fibers used in the UltraLaser Flexible CO2 Laser Waveguides used with your surgical CO2 laser systems:
 
a)  Do not include manufacturing records for the (b)(4) process for fibers manufactured prior to August 2015; for 32 fibers tested on 4/14/15 and for 8 fibers tested on 4/10/13,
b)  Do not include lot numbers for the (b)(4) used for 11 of 12 production runs (48 of 52 batch records) since 8/13/15,
c)  Do not include lot numbers for raw material fibers used in production, and
d)  Include a number of discrepancies between the number of units manufactured and the number of units distributed.
 
We have reviewed your response and have concluded that it is inadequate. Please provide documentation to verify corrective actions have been made. A follow-up inspection will be required to assure that corrections are adequate.
 
4.    Failure to maintain a device master record as required in 21 CFR 820.181.
 
Specifically, temperature specifications are inconsistent for the hollow glass waveguide (b)(4) process. The specifications in your firm’s test record are lower or wider than in your lab Standard Operating Procedure. All 52 batch records reviewed during the inspection (covering the time period 8/13/15-3/10/16) include at least 2 of the 4 temperatures which are outside the specifications you are using.
 
We have reviewed your response and have concluded that it is inadequate. Please provide documentation to verify corrective actions have been made. A follow-up inspection will be required to assure that corrections are adequate.
 
5.    Failure to establish and maintain the requirements, including quality requirements that must be met by suppliers, contractors and consultants as required in 21 CFR 820.50 (a).
 
Specifically,
 
a)  Since 8/31/15, your requirements for vendor qualification were not met for (b)(4), the supplier of 3 lots of (b)(4), used to (b)(4) the hollow fibers. There is no evidence that the supplier is ISO 9000 certified, and there is no documented engineering evaluation done on the silver nitrate as required by your purchasing procedure. None of the 3 lots include lot numbers or any traceability identifiers.
b)  There is no assurance that the sterilization validation supplied by your contract manufacturer conforms to specified requirements.
 
We have reviewed your response and have concluded that it is inadequate. Please provide documentation to verify these corrective actions have been made. A follow up inspection will be required to assure that corrections are adequate.
 
6.    Failure to establish and maintain procedures to control product that does not conform to specified requirements as required in 21 CFR 820.90 (a).
 
Specifically, there is no documentation of the disposition of Hollow Glass Waveguides that failed (b)(4) testing. Between September 2015 and March 2016, at least 28 fibers from 6 runs failed this testing.
 
We have reviewed your response and it appears to be adequate. A follow-up inspection will be required to assure that corrections are adequate.
 
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.
 
An Electronic Product Radiation Control inspection was conducted concurrently with the medical device Quality Systems inspection. In addition to being a "medical device," your firm’s laser products are "electronic products" subject to compliance with Subchapter C of the Act, Electronic Product Radiation Control, the requirements at 21 CFR 1000-1005, and the performance standards at 21 CFR 1040.10, and 1040.11. The following failure to comply with the regulations regarding reports and record keeping (and/or imports) was observed:
 
Failure to submit laser component registration and listing reports, as required by 21 CFR 1040.10(a)(3). For example, the FDA Center for Devices and Radiological Health database shows no component registration and listing reports from your firm.
 
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 (including any systemic corrective actions) 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 the New England District Office. Refer to CMS case 495980 when replying. If you have any questions about the contents of this letter, please contact: Compliance Officer Diane M. Prince at 781-587-7442.
 
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/
Joseph S. Matrisciano, Jr.
District Director
New England District
 
 
Cc:
Dr. Robert I. Rudko, PhD
Vice President and Chief Scientist
W & R Investments, LLC dba Laser Engineering
113 Cedar Street, Suite S-5
Milford, MA 01757

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