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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Light-Tech, Inc. 12/9/11

  

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


 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
WARNING LETTER
 
FLA-12-15
 
December 9, 2011
 
Lance A. Giller, Sr.
President
Light-Tech, Inc.
8900 West Josephine Road
Sebring, Florida 33875
 
Dear Mr. Giller:
 
During an inspection of your firm located in Sebring, Florida, on August 8, 2011, through August 9, 2011, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the 700 series LED Surgical Lamps.  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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. 
 
We received a response from (b)(6), dated August 22, 2011, 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 this response 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 adequate procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). According to your firm’s management, your firm does not have written design control procedures other than the “Minor Design Changes” form, which does not address all of the design control requirements.

Your firm’s response dated August 22, 2011, did not address this issue.

2.  Failure to establish and maintain adequate procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, your firm has not established design change procedures in that:
 
a)    Your firm did not implement design change procedures from halogen bulbs to LED illuminators.
 
b)    Your firm did not include labeling and requirements for risk analysis in the scope of its design change procedures.
 
We cannot determine the adequacy of your firm’s August 22, 2011, response at this time. Your firm’s response stated that, in 90 days, your firm will complete this action. However, to date, your firm has not provided an update to FDA.
 
3.  Failure to establish and maintain 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, your firm’s managers stated that they do not have written procedures for purchasing controls or supplier audits. 
 
Your firm’s response dated August 22, 2011, did not address this issue.
 
4.  Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm did not implement the complaint procedure or review, evaluate, and investigate complaints related to device failures.
 
We cannot determine the adequacy of your firm’s August 22, 2011, response at this time. The response stated that, in 90 days, your firm would complete this action. However, to date, your firm has not provided an update to FDA.
 
5.  Failure to establish and maintain adequate procedures for acceptance activities, which include inspections, tests, or other verification activities, as required by 21 CFR 820.80(a). For example:
 
a)    Your firm does not adequately verify that LED illuminators consistently meet specifications for requirements such as lumen output, temp/color, and longevity. Specifically, your firm’s requirement for LED illuminators is between (b)(4)ºk - (b)(4)ºk; however, bins at the firm contained LED illuminators with specifications between (b)(4)ºk - (b)(4)ºk. 
 
b)    According to your firm, 5 to 10 units of each shipment of power supplies are tested upon receipt; however, this testing is not documented.
 
We cannot determine the adequacy of your firm’s August 22, 2011, response at this time. The response stated that, in 90 days, your firm would complete this action. However, to date, your firm has not provided an update to FDA.
 
6.  Failure to establish and maintain adequate procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). For example, your firm does not include in its CAPA procedure all requirements for corrective and preventive action including, but not limited to:
 
(a)    verifying and validating that the corrective action is effective and does not adversely affect the finished device;
 
(b)    investigating the cause of the nonconformity; and
 
(c)    identifying the action necessary to prevent the recurrence of nonconforming product and other quality problems.
 
We cannot determine the adequacy of your firm’s August 22, 2011, response at this time. The response stated that, in 90 days, your firm would complete this action. However, to date, your firm has not provided an update to FDA.
 
7.  Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). For example, your firm’s managers stated that they do not have a manufacturing procedure for the production of headlights utilizing LED illuminators. 
 
Your firm’s response dated August 22, 2011, did not address this issue.
 
Our inspection also revealed that your firm’s surgical lamp devices are misbranded under Section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:
 
Failure to develop, maintain and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example, your firm did not have a written MDR procedure for a standardized review process or a procedure to determine when an event meets the MDR criteria, or for the documentation of the information that was evaluated to determine if an event was reportable.
 
Our inspection also revealed that the 700 series LED surgical lamps are adulterated under Section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to Section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under Section 520(g) of the Act, 21 U.S.C. § 360j(g).  The device is also misbranded under Section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by Section 510(k) of the Act, 21 U.S.C. § 360(k).  For a device requiring premarket approval, the notification required by Section 510(k) is deemed satisfied when a PMA is pending before the agency.  [21 CFR 807.81(b)]  The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html.  The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
 
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.
 
Your firm’s response should be sent to: Ms. Andrea H. Norwood, Compliance Officer, Florida District Office, Food and Drug Administration, HFR-SE-250, 555 Winderly Place, Suite 200, Maitland, Florida 33751. Refer to the Unique Identification Number CMS case # 234154 when replying.  If you have any questions about the contents of this letter, please contact: Mr. Ronnie E. Jackson at (407) 475-4734 or (407) 475-4769.
 
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,
/S/
Emma R. Singleton
Director, Florida District