Inspections, Compliance, Enforcement, and Criminal Investigations
Innovative Spinal Technologies, Inc. 25-Jun-07
Department of Health and Human Services
Public Health Service
One Montvale Avenue
VIA FEDERAL EXPRESS
June 25, 2007
Mr. Scott Schorer
President & CEO
Innovative Spinal Technologies, Inc.
111 Forbes Blvd.
Mansfield, MA 02048-1153
Dear Mr. Schorer:
During an inspection of your firm located in Mansfield, MA on April 9 through May 8, 2007, investigator(s) from the United States Food and Drug Administration (FDA) determined that your firm manufactures IST Pedicle Screw Systems and Paramount VBR Screw systems. 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 (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:
1. Failure to identify the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3).
During the inspection we observed that your firm has manufactured a total of [redacted] pedicle screw system kits, and that these systems have been used in [redacted] surgical procedures since July 2006. We observed that you often find non-conformances upon the return of the kits after a surgical procedure. During the inspection, we reviewed records for 13 of your pedicle screw system kits. Return inspection records were available for 8 kits and non conforming product was found during 6 of these 8 returns.
We observed that the non conforming implants in returned IST pedicle screw systems have not been investigated to determine why previous quality inspections failed to capture and control nonconforming material.
As an example, we reviewed the IST pedicle screw system kit, [redacted]. This kit was initially inspected on November 15, 2006. It was then on November 29, 2006 and used in a surgery at [redacted]. From your records, a total of 11 components were utilized during this procedure (4 locking caps, 4 6.5 mm pedicle screws 2 PH1 rod assemblies and 1 PH2 rod assemblies). The kit was then returned to IST and inspected on December 14, 2006. This record shows that a 70 mm rod assembly and a PH2 50 mm rod assembly were rejected at that time. There was no documentation available to show why these two products failed at this point when a previous inspection found them acceptable. The kit was then reinspected on January 9, 2007 again for inventory purposes. This record shows that a PH2 45 mm rod assembly was rejected. It also showed that the kit was missing a number of parts since the last inspection on December 14, 2006. A corrective and preventive action (CAPA) was not initiated to investigate the cause of these failures. We observed at least six other instances in which kits were inspected, failures were found, yet your firm took no action to determine the reason for the failure of the devices that had previously passed your own QC inspection.
We acknowledge the receipt of your written response dated June 15, 2007 which addresses the List of Inspectional Observations (Form FDA-483) that was provided to you on May 8, 2007. Your response regarding the above observation indicates that you will include the inspection data on returned kits as a source of quality data. We will need to verify that this is an appropriate correction during FDA's reinspection of your facility to assure that this data is being captured.
2. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).
For example, during our inspection we observed that on at least 4 occasions, nonconforming material reports were not issued when non-conforming material was documented in inspection records of your pedicle screw systems. It is essential that your firm document these non-conformances in reports so that you can evaluate and address the cause of the high rate of non-conformances.
We understand from your June 15, 2007 response that you have trained personnel on the requirements of your procedure for nonconforming material review. We will need to verify this correction during FDA's reinspection of your facility.
3. Failure to document the review and approval process when changes or process deviations occurred within the validation of a process, as required by 21 CFR 820.75(c).
For example, in the validation for the manufacturing process for your Paramount VBR implants, one of your acceptance criteria (step 3.1.2) for the VBR Accelerated Aging and Packaging Validation required that, "The conditioned seal peel strength shall be [redacted] or stronger to the baseline. The final report for this validation stated that the Student's t-test was not performed as specified and as a result no baseline exists against which to compare the accelerated aging test results. There was no documentation available to demonstrate that this failure was deemed acceptable.
Your response indicates that you expect to complete the justification of this protocol deviation on June 29, 2007. We look forward to receiving and reviewing the completed documentation.
4. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product conforms to specified requirements, as required by 21 CFR 820.50.
For example, [redacted] suppliers for your IST pedicle screw components, [redacted] continue to exhibit problems upon receipt of the components by your firm. Three separate CAPAs, dated October, 31, 2006, December 7, 2006 and March 1, 2007, describe continuing problems with defective product being supplied by these two firms. On April 5, 2007 we noted that you opened a fourth CAPA that states the incidence of purchased parts not meeting requirements is unacceptably high and that these problems were identified as early as December 21, 2006. The CAPA describes that the IST supplier process is not effective in selecting, qualifying and evaluating suppliers. However, your firm has continued to receive, inspect and approve components from suppliers with a poor quality history.
Your response indicates that the three separate CAPAs mentioned above have been updated and other CAPAs relating to supply issues are no closed. We also acknowledge that you state that you will no longer be using [redacted] as a supplier. You are reminded that it is your responsibility to assure that all received product conforms to specified requirements. We look forward to receiving and reviewing your plan on how you will prevent these issues from recurring.
5. Failure to establish and maintain 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 made changes to the specifications of rods that are part of your IST pedicle screw system. You removed critical dimension specifications for the incoming inspection of these rods. The ECOs for these changes stated that they were made "to ease manufacturability through specification relief. " There was no documentation available that demonstrated these changes did not impact the safety or efficacy of the device.
Your response indicates that you are in the process of providing technical justification of these changes and will be updating your procedure to assure that any future changes are dealt with appropriately. We look forward to receiving and reviewing this documentation.
6. Failure to establish and maintain procedures for identifying with a control number each unit of finished device that is intended for surgical implant into the body, as required by 21 CFR 820.65.
For example, you market pedicle screws that are intended for surgical positioning of vertebra. You have not documented the lot numbers of any components in your pedicle screw system or in your device history records. Your firm currently assigns each kit a unique serial number; however, the kits are replenished after a surgical procedure and the individual device history records are not maintained to allow for the tracking of the actual implanted screws.
We also observed that 6 out of 14 complaint records reviewed do not include lot or control numbers of the implanted pedicle screw system as required by 21 CFR 820.198(e)(3). Your own SOP 1198 requires device identification be recorded where possible. We acknowledge that these kits are typically in the possession of your own IST sales representatives and believe that this information can be easily recorded. Any complaint investigation would need to include a thorough investigation into the failure and having a lot number to trace back to the supplier is essential for this type of investigation.
Your response explains that all IST products are marked with apart and lot number, yet you are not able to distinguish which lot numbers are being discussed when a complaint is received. Your response also lists two complaints in which the surgeon chose to implant the device, yet there is no lot number associated. Your firm should be able to ascertain what part and lot number is being implanted and would need to perform an investigation into the particular lot number that was the subject of the complaint. Therefore, in your response to this Warning Letter, please address how you will be able to identify each unit in the future.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) 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 violation(s), or similar violation(s), 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 Karen Archdeacon, Compliance Officer, New England District Office. If you have any questions about the content of this letter please contact Ms. Archdeacon at 781-596-7707 or fax 781-596-7899.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) 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 violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Gail T. Costello
New England District