Inspections, Compliance, Enforcement, and Criminal Investigations
Spinal, USA 07-Dec-07
Department of Health and Human Services
Public Health Service
New Orleans District
December 7, 2007
WARNING LETTER NO. 2008-NOL-05
Jeffrey B. Johnson, President
644 Lakeland East Drive, Suite A
Flowood, Mississippi 39232
Dear Mr. Johnson:
During an inspection of your firm, located at 644 Lakeland East Drive, Suite A, Flowood, Mississippi, on May 30 - 31, June 4 and 6, 2007, investigators from the United States Food and Drug Administration (FDA) determined your firm manufactures the Slimplicity Anterior Cervical Plate System, the Spinal USA Cement Restrictor and the Spinal USA Vertebral Body Replacement (VBR) System. 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 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, Part 820 (21 CFR 820). Our investigators' observations were noted on the Form FDA 483, List of Inspectional Observations (483) issued to you on June 6, 2007. These violations include, but are not limited to, the following:
1. You failed to review, update, and approve the plans which describe or reference the design and development activities for the devices [21 CFR 820.30(b)]. For example, the current specifications and diagrams for the Cement Restrictor System, Anterior Cervical Plate Assembly, and the VBR System you had on file for these devices did not match the specifications and diagrams of the contract manufacturer for these same devices.
2. You failed to establish and maintain procedures for the identification, documentation, validations, or where appropriate, verification, review and approval of design changes before their implementation [21 CFR 820.30(i)]. Several of these instances were noted during the inspection as the specifications did not match the manufacturer's specifications.
3. You failed to establish and maintain a design history file for each type of device [21 CFR 820.30(j)]. For example, there are two different design plans for the Anterior Cervical Plate Assembly, one used by the contract manufacturer and one on site at the specification developer.
4. You failed to establish and maintain procedures to ensure the device design is correctly translated into production specifications [21 CFR 820.30(h)]. For example, the current device diagram/specification on file for the Cement Restrictor (CR) System was dated January 1, 2006, and entitled CR System Revision #2. The contract manufacturer's current device diagram/specification for the CR was dated March 1, 2006, and entitled CR System Revision #A. The two different design plans for the CR diagram/specifications on file have not been reviewed, updated, or approved to show the manufacturer is using the same specifications as the developer to create the same device.
5. You failed to maintain device master records (DMR) which include device specifications, including appropriate drawings, composition, formulation, component specifications, and software specifications [21 CFR 820.181(a)]. For example, although you contract with a company to manufacture your devices, you are required, as a manufacturer (specifications developer), to maintain DMR at your facility. You had no such records at your facility.
6. You failed to maintain device history records (DHR) [21 CFR 820.184]. For example, there are no procedures to ensure the DHR for each batch, lot, or unit is maintained to demonstrate the devices are manufactured in accordance with the DMR and the requirements of 21 CFR Part 820. Further, you do not have information on the dates of manufacture, quantity manufactured, quantity released for distribution, acceptance records, primary identification labeling for each production unit, and device identification and control number(s) used for the devices you manufacture.
7. You failed to have management with executive responsibility establish the policy and objectives for, and commitment to, quality and to ensure the quality policy is understood, implemented, and maintained at all levels of the organization [21 CFR 820.20]. For example, you have no QS in place to control and monitor the development, repackaging, and labeling of finished medical devices. You failed to establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mix-ups [21 CFR 820.60]. For example, upon receipt of devices from the contract manufacturer, devices are labeled and placed into stock. At this point, the devices are available for distribution. However, there is no documentation the correct device was received and labeled with the correct label, and shipped to the correct customer.
8. You failed to establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mix-ups [21 CFR 820.20]. For example, upon receipt of devices from the contract manufacturer, devices are labeled and placed into stock. At this point, the devices are available for distribution. However, there is no documentation the correct device was received and labeled with the correct label, and shipped to the correct customer.
9. You failed to establish and maintain procedures for the control and distribution of finished devices to ensure only those devices approved for release are distributed and purchase orders are reviewed to ensure ambiguities and errors are resolved before devices are released for distribution [21 CFR 820.160(a)]. For example, the nine assembled surgical kits include the various implantable devices and the tools to assist in their placement. There are replacement parts which are interchanged on occasion with no procedures to control the correct components are placed in the correct kit.
10. You failed to establish and maintain procedures to control labeling activities [21 CFR 820.120]. For example, all labels are maintained and generated by a computer. There are no labeling procedures, and no labels contained the required prescription legend for the implantable devices.
Our inspection revealed your devices are misbranded under Section 502(f)(1) of the Act, 21 USC 352(f)(1), because your devices do not bear adequate directions for use and do not bear the required labeling for prescription devices, as required by 21 CFR 801.109, as "Caution: Federal law restricts this device to sale by or on the order of a physician."
Your devices are misbranded under Section 502(t)(2) of the Act, 21 USC 352(t)(2), because your firm failed to furnish any material or information respecting the device, as required by or under Section 519 of the Act, 21 USC 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR) regulation. Specifically, you failed to develop, maintain, and implement written MDR procedures for internal systems and documentation and record keeping, as required by 21 CFR 803.17.
Our inspection revealed the 7 mm cervical cage is adulterated within the meaning of 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 (PMA) in effect pursuant to Section 515(a) of the Act, 21 USC 360e(a), or an approved application for an investigational device exemption (IDE) under Section 520(g) of the Act, 21 USC 360j(g). The device is misbranded under Section 502(o) of the Act, 21 USC 352(o), because you did not notify the Agency of your intent to introduce the device into commercial distribution, as required by Section 510(k) of the Act, 21 USC 360(k). For a device requiring PMA, the notification required by Section 510(k) of the Act is deemed satisfied when a PMA is pending before the agency [21 USC 807.81(b)]. The kind of information you need to submit in order to obtain approval or clearance for your device is described on the internet at http://www.fda.gov/cdrh/devadvice/3122.html. FDA will evaluate the information you submit and decide whether your product may be legally marketed.
You are also in violation of Section 502(o) of the Act, 21 USC 352(o), because you currently are registered only as a specification developer and not properly registered as a packager and re-labeler .
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 about devices so they may take this information into account when considering the award of contracts. Additionally, PMA applications for Class III devices to which the QS regulation deviations reasonably are 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 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 Karl L. Batey, Compliance Officer, U.S. Food and Drug Administration, at the above address. If you have any questions about the content of this letter, please contact Ms. Batey at (615)366-7808.
Finally, you should know 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 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.
H. Tyler Thornburg
New Orleans District