September 1, 2015

Troy Innovative Instruments Inc.

During an inspection of your firm located in Middlefield, OH on June 5 through 30, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a contract manufacturer of various tools and implantable orthopedic devices, including trocars, lumbar bone screws, rods, nuts and plates. 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 (CFR), Part 820. We received a response from you, dated July 14, 2015, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you.

We address this response at the end of the list of the violations. These violations include, but are not limited to, the following:

  1. Failure to validate a process, whose results cannot be fully verified by subsequent inspection and test, with a high degree of assurance according to established procedures, as required by 21 CFR § 820.75(a). Specifically,
    • The validation studies of the laser etching process, used to etch lot numbers on implantable devices and orthopedic tools, did not include testing whether the laser etching process adversely affects the device regarding post processing metal fatigue.
    • The validation studies for the Nitric passivation process did not test the worst case scenario for load size. A total of 300 devices are routinely processed during the passivation process. Only 190 pieces of test article were processed during the validation studies.
    • The validation studies for the TIG welding processes, which is used to manufacture several medical instruments, did not include strength testing of the welds. Also, you do not have data to support you meet the post heat treat tensile strength test at the weld site for any of the parts.
    • You have not validated your tumbling process, which can create burs that can affect device performance and can remove edges on critical dimensions which may not be detectable.
    • The validation studies for the electropolishing (EPI) of medical devices did not use the worst case scenario for testing.
    • The validation studies for the manual/sonic cleaning of medical devices, which refer to using ASTM standard 7.2.1 as the visual check for processing oils and residues, did not include evidence that supplemental lighting or a borescope was used during the visual inspection, which is a requirement in the standard.
  2. Failure to document a determination of whether there has been any adverse effect from rework upon the product, as required by 21 CFR § 820.90(b)(2). Specifically, You have not conducted testing or analysis to show that nonconforming products re-subjected to validated processes, such as re-passivation, re-cleaning, and re-polishing, are not adversely affected.
  3. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR § 820.90(a). Specifically, your “CONTROL OF NONCONFORMING PRODUCT” procedure, DOC # WI 8.3, Rev J, dated March 25, 2015 is not adequate in that:
    • Non-conforming products were not accounted for on 2/2 manufacturing workstations inspected.  1) Seven scrap parts for part number 012.1408/ lot 18935 were recorded on FM803 log, but the FDA investigator observed twenty parts in the scrap bin.  2) Eighty-four scrap parts for part number ISB-000-000/ lot 18856 were recorded on FM803 log, but the FDA investigator observed ninety-five parts in the scrap bin.
    • All nonconformances are not being recorded. When non-conformities are reported to the supervisor, as required by your procedure, WI 8.3, and the product is re-tested or re-measured by the supervisor and subsequently pass; there is no record of the original non-conformance or the root cause of the original failure.
  4.  Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR § 820.50.  Specifically, your “SUPPLIER QUALIFICATIONS” procedure, Doc #QMP 7.4.2, Rev F, dated January 6, 2014 is not adequate in that:  You are not evaluating and monitoring suppliers on their ability to meet requirements, including quality requirements. 1) Suppliers are approved and continue to be used without documented review of whether processes used by the supplier, such as passivation, heat treatment and electroplating, are validated, monitored, and/or acceptable. 2) Your annual review does not include reviewing your supplier’s ability to meet specified requirements, including quality requirements; and does not include reviewing non-conformances that are not part of a formal supplier corrective action. Your procedure is inadequate in that it states that you will annually evaluate your top 4 raw material suppliers and top 4 subcontractors by dollar volume, plus one other supplier chosen at random. Additionally, the annual review only rates your suppliers based on late deliveries, dollars rejected, and responsiveness to issued corrective actions.
  5. Failure to document in-process inspections, test, or other verification activities and approvals, as required by 21 CFR § 820.80(c). Specifically, Per “IN PROCESS INSPECTION” procedure, WI 7.5.1-2, Rev J, dated August 28, 2013, you are to perform in-process inspections based on the established sampling plan for specified critical dimensions. These inspections are not documented.

We cannot determine the adequacy of your response at this time. Your response states that you have opened several CAPAs to address the observations listed on the FDA-483, but copies of these CAPAs and other supporting documentation were not submitted with your response.  Additionally, your response states that you will revise process validations and procedures; review the surface finishing processes with your customers to ensure that the process operating windows are validated; revise procedures relating to scrap documentation; address problems with your control of nonconforming product; revise your supplier qualification procedures; write work instructions for the tumbling process; validate the tumbling process and revise your in-process acceptance activities procedures. Please provide detailed information on your corrective actions, as described in the below paragraphs.

Your firm 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.

We are requesting that you submit to this office on the schedule below, certification by an outside expert consultant that he/she has conducted an audit of your establishment’s manufacturing and quality assurance systems relative to the requirements of the device QS regulation (21 CFR, Part 820). You should also submit a copy of the consultant’s report, and certification by your establishment’s Chief Executive Officer (if other than yourself) that he or she has reviewed the consultant’s report and that your establishment has initiated or completed all corrections called for in the report. The initial certifications of audit and corrections and subsequent certifications of updated audits and corrections (if required) should be submitted to this office by the following dates:

  • Initial certifications by consultant and establishment – March 1, 2016
  • Subsequent certification – March 1, 2017

Please notify this office in writing within fifteen business 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 corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.

Your firm’s response should be sent to: Ms. Gina M. Brackett, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions about the content of this letter, please contact: Ms. Brackett at (513) 679-2700 extension 2167 or fax at (513) 679-2775.

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 firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

Download FDA Warning Letter in PDF

FDA Warns a Device Firm of Validation Studies of the Laser Etching Process
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