Inspections, Compliance, Enforcement, and Criminal Investigations
Sandstone Medical Technologiess, LLC 30-May-08
Department of Health and Human Services
Public Health Service
New Orleans District
Telephone: (615) 366-7801
May 30, 2008
WARNING LETTER NO. 2008-NOL-11
DELIVERY SIGNATURE REQUESTED
Mark C. Rohrer, Managing Member
Sandstone Medical Technologies, LLC
102 Oxmoor Road, Suite 130
Birmingham, Alabama 35209
Dear Mr. Rohrer:
On April 8, 10 and 18, 2008, a U.S. Food and Drug Administration (FDA) investigator inspected your firm, located at 102 Oxmoor Road, Suite 130, Birmingham, Alabama. Our investigator determined your firm is an initial importer, manufacturer, and relabeller of several Class II Medical Laser Systems. These products are Medical Devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 321(h)]. More specifically, they are laser surgical instruments as defined in Title 21, Code of Federal Regulations, Section 878.4810 (21 CFR 878.4810). You may find the specific regulations through links in FDA Internet home page at http://www.fda.gov.
Your devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], as 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) regulation found in 21 CFR 820. On April 18, 2008, our investigator documented significant violations of CGMP and QS regulations, which were discussed with you, including, but not limited to, the following:
1. Failure to ensure an adequate and effective quality system has been fully established, implemented, and maintained at all levels of the organization by management with executive responsibility, as required by 21 CFR 820.20. [Reference: Form FDA 483, Observation 1] Your firm failed to establish a quality policy and to ensure it is followed. Specifically, your firm has no documented quality system procedures for the manufacturing and distribution of the laser systems, which would include device master records, device history records, and acceptance activity records. Furthermore, your firm has not established procedures for performing quality audits, identifying training needs, design control, document control, purchasing controls, change control, process controls, labeling controls, finished device marketing and distribution, and control and disposition of non-conforming product or complaint handling.
2. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA) procedures, as required by 21 CFR 820.100(a). [Reference: Form FDA 483, Observation 3] Specifically, your firm has no written CAPA procedures for your devices.
3. Failure to establish and maintain complaint files and associated procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). [Reference: Form FDA 483, Observation 4] Additionally, your firm failed to evaluate complaints to determine whether they represent an event which is required to be reported to the FDA by 21 CFR 803 -- Medical Device Reporting (MDR) regulation. Our investigator collected ten service reports which appeared to be complaints. One report, dated October 31, 2006, may represent an event which required reporting per MDR regulation. The reports include:
• Report, dated February 19, 2008, of UltraLight Q, Serial Number 060309, "will not turn on"-,
• Report, dated October 31, 2007, of UltraLight Q, Serial Number 050307, "not firing or fires by itself';
• Report, dated July 12, 2007, of UltraLight Q, Serial Number 170208, "low power";
• Report, dated November 9, 2006, of UltraLight Q, Serial Number 051415, "burned patient";
• Report, dated September 7, 2006, of UltraLight Q, Serial Number 051415, "low power";
• Report, dated July 6, 2006, of UltraLight Q, Serial Number 050811, "not firing";
• Report, dated June 21, 2006, of [redacted] Serial Number [redacted] "200 mj burning hot";
• Report, dated March 22, 2006, of [redacted] Serial Number [redacted] "laser firing after release of footswitch";
• Report, dated February 27, 2006, of UltraLight Q, Serial Number 041008, "F.S. too sensitive" (i.e., footswitch too sensitive); and,
• Report, dated February 7, 2006, of UltraLight Q, Serial Number 050305, "will not fire".
4. Failure to establish and maintain servicing instructions and procedures, as required by 21 CFR 820.200(a). [Reference: Form FDA 483, Observation 5] Specifically, the product manual for your UltraLight laser system includes specific servicing provisions. Per 21 CFR 820.200, servicing instructions and procedures are required where servicing is a specified requirement by the manufacturer. Additionally, your firm failed to evaluate service reports, as required by 21 CFR 820.200(c), to determine whether they represent a complaint event required to be reported to the FDA by 21 CFR 803 -- MDR regulation.
5. Failure to establish and maintain procedures for acceptance activities, as required by 21 CFR 820.80(a). [Reference: Form FDA 483, Observation 6] Specifically, your firm conducts product testing and relabeling on your imported lasers before release for distribution Additionally, your firm does not maintain records documenting these activities, as required by 21 CFR 820.80(e).
6. Failure to establish procedures for identifying training needs and ensuring all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). [Reference: Form FDA 483, Observation 7] Specifically, your firm does not maintain records documenting employees have the necessary education, background, training, and experience to ensure acceptance activities, complaint handling, medical device reporting, labeling, servicing, and repairs are conducted correctly.
7. Failure to submit annual reports for the laser systems, as required by 21 CFR 1002.13. [Reference: Form FDA 483, Observation 8] Since your firm is the initial importer, official correspondent, and U.S. agent for a foreign contract manufacturer of Class IV medical lasers, which are distributed under your firm's brand name(s), your firm is required to submit annual reports. Other required records and reports include, product and supplemental reports, and test and distribution records (21 CFR 1002.10, 1002.11, and 1002.30).
The inspection also revealed your devices are misbranded under Section 502(t)(2) of the Act [21 USC 352(t)(2)], as your firm failed or refused to furnish material or information regarding the devices, as required by Section 519 of the Act [21 USC 360i, and 21 CFR 803 -- MDR regulation]. Specifically, you failed to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. [Reference: Form FDA 483, Observation 2] Your firm has no written MDR procedures and does not have an internal system to provide for effective identification, communication, and evaluation of events that may be subject to MDR requirements. Furthermore, your firm does not have a standardized review process or procedures for determining when an event meets the criteria for reporting required by the MDR regulation.
Additionally, though not discussed with you, the identification label, applied to each medical laser, fails to include the month and year of manufacture, which is required by 21 CFR 101 0.3(a)(2)(11).
Regarding your firm's marketing of your UltraLight Q ND: YAG Laser System, and the repaired, used medical lasers, we advise you to contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at the Center for Devices and Radiological Health (CDRH) to determine what approval is necessary for you to market and distribute these products within the United States. Because you lack clearance or approval for your UltraLight Q ND: YAG Laser System devices, marketing these devices for their intended use is a violation of the law. Specifically, your devices are adulterated under Section 501(f)(1)(B) of the Act, [21 USC 351(f)(1)(B)] because you do not have an approved application for premarket approval in effect pursuant to Section 515(a) of the Act [21 USC 360e(a)] or an approved application for an investigational device exemption under Section 520(g) of the Act [21 USC 360j(g)]. The kind of information you need to submit in order to obtain approval or clearance for your device can be accessed at http://www.fda.gov/cdrh/devadvice/36f.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
All laser devices distributed for human and/or animal treatment in the United States are subject to Mandatory Performance Standards. They must meet the Federal laser product performance standard and manufacturers must submit an "initial report" to CDRH's Office of Compliance before distributing the product. [See 21 CFR 1000-1040.11] The performance standards specify the safety features and labeling all laser products must have in order to provide adequate safety to users and patients . Laser product manufacturers must certify each model complies with the standard when introducing such product into United States commerce. [See 21 CFR 1010.2] This includes distribution for use during clinical investigations before device approval. Specifically, required standards for medical laser products are provided in 21 CFR 1040.10 and 1040.11.
Certification of a laser product means each unit has passed a quality assurance test and complies with the respective performance standard. [See 21 CFR 1010.2] Firms certifying a laser product are responsible for product reporting, recordkeeping, and notification of defects, noncompliance, and accidental radiation occurrences, as specified in Sections 21 CFR 1000-1010. A certifier of a laser product is required to report the product via a Laser Product Report submitted to CDRH. Reporting guides and related regulatory information are available from the DSMICA web site at http://www.fda.gov/cdrh/devadvice.
This letter may not list all the deficiencies at your facility. You are responsible for ensuring your firm adheres to all requirements of the Act and regulations applicable to medical devices. Federal agencies are advised of the issuance of all warning letters about devices so they may take this information into account when considering the award of contracts. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action, including seizure, injunction, and/or civil money penalties, without further notice.
Please respond in writing within 15 working days of your receipt of this letter outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include each step taken to correct the violations and prevent their recurrence. You should include in your response documentation, such as written procedures, label samples, completed forms, MDR submissions, and other useful information to assist us in evaluating your corrective actions. If corrective action cannot be completed within 15 working days, we expect you to explain the reason for the delay and state when the remaining deviations will be corrected.
Please send your reply to the U.S. Food and Drug Administration, Attention: Rebecca A. Asente, Compliance Officer, at the above address. If you have questions regarding issues in this letter, please contact Ms. Asente at (504) 219-8818, extension 104.
H. Tyler Thornburg
New Orleans District
Enclosure: Form FDA 483