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  5. Isolux, LLC - 01/08/2016
  1. Warning Letters


Isolux, LLC

Isolux, LLC

United States

Issuing Office:
Florida District Office

United States


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

Public Health Service
Food and Drug Administration
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
FAX: 407-475-4770 


January 8, 2016
Mr. Paul L. Beech, Managing Member
IsoLux, LLC.
1045 Collier Center Way, Suite 6
Naples, FL 34110
DearMr. Beech:
During an inspection of your establishment located in Naples, FLon November 4, 2015 through November 6, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures A/C Powered Illuminators. 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 are intended to affect the structure or 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. 
These violations include, but are not limited to, the following:
1.      Failure to adequately establish procedures for corrective and preventive actions (CAPA) as required by 21 CFR 820.100(a). Specifically, your firm conducted CAPA activities related to spot uniformity and homogeneity of your fiber optic cable illumination and misalignment of your Isovu Headlight Camera System in March 2011. The records for these CAPAs did not include documentation related to your investigation into underlying causes and verification or validation of the corrective action. 
This is a continued observation from previous inspections of your firm in January 2010 and August 2005.
2.      Failure to adequately establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements as required by 21 CFR 820.50. Specifically, Section 4.2 of your Quality System Regulation Manual (QSRM) outlines your purchasing controls. Your firm did not implement these procedures to adequately qualify the new supplier of your fiber optic cables in 2011.  
This is a continued observation from previous inspections of your firm in January 2010 and August 2005.
3.      Failure to adequately establish procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). Specifically, your firm relies on your suppliers’ Certificates of Analysis and a UL certification for incoming products. These activities do not ensure that these incoming products meet your product specifications.
4.      Failure to establish and maintain procedures for design change, as required by 21 CFR 820.30(i). Specifically, Section 2 of your QSRM outlines your firm’s procedures for design change. These procedures do not include requirements for the identification, documentation, validation or verification, and approval of design changes prior to implementation.
5.      Failure to establish and maintain a design history file (DHF) for each type of device, as required by 21 CFR 820.30(j). Specifically, your firm has not established a DHF for your 1180 XSB Xenon Light Source devices to demonstrate that the design was developed in accordance with an approved design plan. Additionally, a review of your DHF did not include documented evidence that the design was approved for transfer into production.
We acknowledge receipt of your response on December 1, 2015 concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), Inspectional Observations, issued to your firm on November 6, 2015. Your response did not provide adequate supporting evidence that the referenced corrections and planned courses of action have been implemented. 
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 (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.
Please send your reply to the U.S. Food and Drug Administration, Attention: Andrea H. Norwood, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions regarding any issues in this letter, please contact Dr. Norwood by telephone at (407) 475-4724. 
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. 
Susan M. Turcovski
Director, Florida District
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