Inspections, Compliance, Enforcement, and Criminal Investigations
SSI Laser Engineering Inc 1/7/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
January 7, 2009
WARNING LETTER No. 09-NOL-02
Delivery Signature Requested
Louis Wallace, President
SSI Laser Engineering, Inc.
1650 Elm Hill Pike, Suite 5
Nashville, Tennessee 37210-3626
Dear Mr. Wallace:
During an inspection of your firm, SSI Laser Engineering Inc., located at 1650 Elm Hill Pike, Suite 5, Nashville, Tennessee, on October 15, 16, and 17, 2008, investigators from the United States Food and Drug Administration (FDA) determined your firm manufactures carbon dioxide 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 do not conform with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulations found at Title 21, Code of Federal Regulations, Part 820 (21 CFR 820). These violations include, but are not limited to, the following:
1. You failed to establish procedures for conducting management reviews for determining if your quality policy and quality objectives are being met, and to ensure the continued suitability and effectiveness of the quality system, as required by 21 CFR 820.20(c). Specifically, you failed to establish procedures to define the management review system.
2. You failed to ensure all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b).
a. Your training procedure requires your management to be trained in the QS regulations and CGMPs to evaluate the effectiveness of the system; however, you failed to train employees on the QS regulation and CGMP requirements.
b. You failed to train the contract service technicians employed by your surgical laser distributors on your service requirements and service procedures.
3. You failed to establish and maintain procedures for implementing corrective and preventative action (CAPA), as required by 21 CFR820.100(a). For example, your CAPA procedures address the operations of [(b)(4)] a contractor. Those procedures instruct your management to evaluate your Corrective Action Request (CAR) log monthly. This procedure does not address evaluating data from returned merchandise authorizations, service reports, and other sources. Furthermore, you failed to implement the procedure in that you did not document review of your CAR log.
4. You failed to review and evaluate all complaints to determine whether an investigation is necessary, as required by 21 CFR 820.198(b). For example, you failed to document the reason an investigation was not made on eleven service reports you received between January 31, 2007 and September 25, 2008.
5. You failed to document service activities performed by your contract service entity, the distributors, and those performed by remote internet access, as required by 21 CFR 820.200(d). For example, you failed to maintain service reports for servicing activities performed on your lasers by [(b)(4)]
6. Your procedures have not been signed by an approving official, as required by 21 CFR 820.40(a). Specifically, none of your procedures include the signature of the approving official.
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 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 concerning 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 QS 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 recurring. 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 actions 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 U.S. Food and Drug Administration, Attention: Mark W. Rivero, Compliance Officer at the above address. If you have any questions about the content of this letter, please contact Mr. Rivero at (504) 219-8818, extension 103.
This letter is not intended to be an all-inclusive list of 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 conclusion 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 bring your products into compliance.
H. Tyler Thornburg
New Orleans District
Enclosure: Form FDA 483