Inspections, Compliance, Enforcement, and Criminal Investigations
Avicenna Laser Technology Inc 30-Nov-07
Department of Health and Human Services
Public Health Service
555 Winderley PL., Ste. 200
RETURN RECEIPT REQUESTED
November 30, 2007
Dr. Bruce R. Coren
Chairman and CEO
Avicenna Laser Technology, Inc.
1209 N. Flagler Drive
West Palm Beach, Florida 33401-3509
Dear Dr. Coren:
During an inspection of your firm located at the above address on July 12-13, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures AVI HP-7.5 Class IV therapeutic laser system for multi-specialty application in bio-stimulation. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), (21.U.S.C. 321(h)), this product is a device because it is intended for use, in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of,the body.
This inspection revealed that this device is 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, its 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,(C.F.R.), Part 820.
These violations include, but are not limited to, the following:
. Failure to establish and implement written procedures for the following:
Failure to establish procedures to control the design process, as required by 21 CFR 820.30(a). Specifically, you failed, to establish design control procedures before development of the model AVI HP-75 Class II medical lasers. Review of Design Master Record for the AVI HP-75 model revealed that you failed to include design inputs, outputs, reviews, transfers and management approvals before the lasers were manufactured by the OEM manufacturer.
Failure to establish procedures for identifying training needs and to ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820 .25(b). Specifically, employees responsible for receiving finished medical lasers from the OEM manufacturer, conducting receiving inspections, collecting information for and preparing the device history reports (DHR), final releasing, and shipping finished devices to customers, failed to ensure that all DHR contained all required information and inspection reports before releasing the devices. Training was not documented.
. Failure to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). For example, your firm uses several contractors and suppliers and none have been evaluated.
. Failure to have the signature of a designated individual(s) prior to releasing finished devices for distribution, as required by 21 CFR 820.80(d)(3).
. Failure to implement the procedures for the acceptance or rejection of incoming product, including the documentation of acceptance or rejection, as required by 21 CFR 820.80(b). Specifically, your firm's SOP, 20.80, Acceptance Activities, requires [redacted] of the received finished devices and performance of a [redacted] Review of 36 of 74 DHR for both models of medical lasers failed to include the [redacted] document. In addition, for all DHR but 4 reviewed, the OEM manufacturer failed to document the actual test values (dB) of the [redacted] for the audible emission indicator and [redacted] diameter measurement tests.
. Failure to implement procedures to control documents required under the Quality Systems regulation, as required by 21 CFR 820.40. Specifically, your firm failed to follow document control procedures when corrections were made to firm records and procedures subsequent to the previous FDA inspection. Responses to FDA reported that corrections were made; however not all changes resulted in new document revision approvals.
It was noted during the inspection that existing device information changed. Specifically, your firm discontinued purchasing your Class II medical laser, model VTR-75 manufactured by one OEM manufacturer, and replaced it with model AVI-HP 7.5, manufactured by another OEM, without submitting a new 510(k) notice or filing a supplement to the existing cleared 510(k) notice. Failure to submit a new 510(k) notice or to supplement the cleared 510(k) notice may cause your devices to be misbranded under Section 502(o) of the Act.
We have not received annual reports for the therapeutic laser system, as required by 21 CFR 1002.13. You may download the document "Guide for Filing Annual Reports for X-Ray Components and Systems" for your use from our web site at http://www.fda.gov/cdrh/radhlth/pdf/xrcrptOa.pdf.
In addition, the identification label failed to include the month and year of manufacturer as required by 21 CFR 1010.3(a)(2)(ii).
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 the Food and Drug Administration 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 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 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.
Please notify this office in writing within fifteen (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 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 response should be sent to Brant M. Schroeder, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, (407)475-4763.
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 (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.
Director, Florida District