Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kelyniam-global-inc-527408-10052017
Timestamp: 2019-08-23 15:50:33
Document Index: 20160109

Matched Legal Cases: ['§ 321', 'art 803', '§ 351', '§ 360', '§ 360', '§ 352']

Kelyniam Global, Inc. - 527408 - 10/05/2017 | FDA
Kelyniam Global, Inc. - 527408 - 10/05/2017
Kelyniam Global, Inc. MARCS-CMS 527408 — Oct 05, 2017
Tennyson S. Anthony
CMS #527408
During an inspection of your firm located in Canton, Connecticut on May 10, 2017 through May 30, 2017, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures patient-specific cranial implants and maxillofacial implants. 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 to affect the structure or any function of the body.
We received a response from Dr. Mark V. Smith, Director, dated June 20, 2017, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations.
1. Failure to establish and maintain design change procedures, pursuant to 21 CFR 820.30(i). For example, your firm failed to perform design validation for the following significant design changes:
a. A product modification was implemented, adding a new implant feature to cranial implants, identified as the Temporal Suture System (TSS) which was requested under Intake Request 001292, opened on 03/07/2014. The modification includes the addition of an advanced suture/perfusion hole pattern, which is an alternate series of hole designs and a suturing protocol used to suture the muscles of the temporal region to the Kelyniam PEEK cranial implant. The Intake Request states that your firm was already producing these hole patterns on patient implants when requested. Further, your instructions for use were modified to include the TSS on 10/01/2016.
b. The Integrated Fixation System was added as an option to use with your implants, which consists of an alternate fixation method utilizing tabs with the cranial implant, along with a fixation protocol. The system also included recommendation for using a compatible screw type, and you did not ensure that the labeling specifies requirements for compatible screws.
c. The Integrated Fixation System was changed to include a counterbore to countersink design in 2014, and the change was not reflected in your instructions for use until 2016.
d. The Integrated Fixation System’s recommended screw specifications were changed in 2016, and validation/verification has not been completed to date.
We reviewed your firm’s response and conclude that it is not adequate. While your firm provided a timeline for estimated completion of corrective actions including a gap analysis on core procedures, work instructions, and forms/templates, you have not provided any supporting documentation. For example, your response states that you will create a CAPA and evaluate related design control documents. Your response also states that you will be implementing labeling changes including the removal of any reference to the Temporal Suturing System, however, no evidence was provided.
2. Failure to evaluate complaints to determine whether the complaint represents an event which is required to be reported to the FDA under 21 CFR Part 803, Medical Device Reporting, pursuant to 21 CFR 820.198(a)(3). For example:
a. Your firm failed to investigate the reason for medical devices that are re-ordered since 2015. One re-order, (b)(4), for a PEEK-IM1004 implant, involved a patient infection and your firm failed to investigate the matter further, including evaluation for MDR reportability.
b. Complaint investigations do not require evaluating if there was a related injury, death, infection, or extension in surgery. The Medical Device Reporting Form, QF-85-01-1, is also not being used to evaluate complaints. Examples of complaints in which the form was not completed includes: Intake Request 1408 (for implant fit problems); Intake Request 1416 (for implant fit problems); and Intake Request 1452 (for some perfusion holes missing and placed incorrectly).
We reviewed your firm’s response and conclude that it is not adequate. While your firm provided a timeline for estimated completion of corrective actions including a gap analysis on core procedures, work instructions, and forms/templates, you have not provided any supporting documentation to demonstrate that you have retrospectively reviewed re-orders and intakes for purposes of conducting complaint investigation or evaluating for MDR reportability. Your response states that you will create a CAPA and evaluate related complaint/MDR procedures, however, no evidence was provided.
3. Failure to demonstrate that the device was manufactured in accordance with the device master record, pursuant to 21 CFR 820.184.
For example, (b)(4), A10CSI-4-60, explains the (b)(4) and (b)(4). However, (b)(4) for cranial implants and maxillofacial implants are not documented in Device History Records (DHR). Examples of DHRs which fail to include this testing includes: CSI020317-JB1, CSI1010517-JH1, CSI031317-RW1, CSI042617-BW1, CSI032217-BG1, CSI041417-KK1, CSI020217-GL1, CSI032817-MB1, and CSI022117-HM1.
We reviewed your firm’s response and conclude that it is not adequate. While your firm provided a timeline for estimated completion of corrective actions including a gap analysis on core procedures, work instructions, and forms/templates, you have not provided any supporting documentation. For example, your response states that you will create a CAPA in order to review documents related to the DHR, however, no evidence was provided.
4. Failure to validate a process whose results cannot be fully verified by subsequent inspection and test according to established procedures, pursuant to 21 CFR 820.75(a). For example:
a. The (b)(4) sterilization validation for custom skull implants was performed using (b)(4) that had not undergone the complete manufacturing process. Further, there is no review and approval of this report by management.
b. There is no process validation for the manufacture of cranial implants on CNC equipment, in addition to the fixture that is used with the CNC equipment for machining of cranial and maxillofacial implants.
c. The cleaning validation for the implants consists of (b)(4) test reports, which do not identify the specific product being tested. Further, there is no review and approval of these reports by your firm, nor explanation for the test results being acceptable.
We reviewed your firm’s response and conclude that it is not adequate. While your firm provided a timeline for estimated completion of corrective actions including a gap analysis on core procedures, work instructions, and forms/templates, you have not provided any supporting documentation. Your response states that you will create a CAPA and evaluate related validation documents, however, no evidence was provided.
5. Failure to establish procedures for acceptance of incoming product, pursuant to 21 CFR 820.80(b).
a. The supplier was changed for the PEEK used in the manufacturing of the implants, however, your PEEK Material Change Documentation, A10CSI-0-20, does not require that the properties of the new material meets a standard or a defined set of specifications.
b. The Incoming Material Inspection Tag for PEEK requires the presence of a certificate of compliance (COC), however, there are no specifications established for which the COC should be compared against. Purchasing Procedure, QOP-74, requires that devices with a Certificate of Conformance (COC) be checked for “completeness”, however, does not define the criteria which must be met.
We reviewed your firm’s response and conclude that it is not adequate. While your firm provided a timeline for estimated completion of corrective actions including a gap analysis on core procedures, work instructions, and forms/templates, you have not provided any supporting documentation. Your response states that you will create a CAPA and evaluate related acceptance criteria documents, including determination of a standard and predetermined specifications for acceptance of PEEK, however, no evidence was provided.
6. Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system, pursuant to 21 CFR 820.20(c). For example, Management Review had not been performed since January 11, 2016, however, your Management Review Procedure QOP-56, requires a minimum of two meetings per year.
We reviewed your firm’s response and conclude that it is not adequate. While your firm provided a timeline for estimated completion of corrective actions including a gap analysis on core procedures, work instructions, and forms/templates, you have not provided any supporting documentation. Your response states that you will create a CAPA and evaluate related management review processes and documents, however, no evidence was provided.
7. Failure to establish corrective and preventive actions procedures, pursuant to 21 CFR 820.100(a).
For example, nonconformance Intake Request 001488, created 02/10/2016 for incomplete training records, did not include verification that all employees are trained on procedures which have had significant changes. Due to the ineffective corrective action, it was observed that the operator of the Computer Numerical Control (CNC) equipment, which is used for the machining of the implant from the polymer PEEK, was not trained on the most current revision of the (b)(4), A10CSI-3-10 Rev A4, dated 10/16/2015, which is for the setting of the fixture in the CNC equipment.
We reviewed your firm’s response and conclude that it is not adequate. While your firm provided a timeline for estimated completion of corrective actions including a gap analysis on core procedures, work instructions, and forms/templates, you have not provided any supporting documentation. Your response states that you will create a CAPA and evaluate Document/Change Control Records, Training, Nonconforming Material Records, and CAPA procedures, however, no evidence was provided.
Our inspection also revealed that the Kelyniam Customized Cranial/Craniofacial Implants are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), in that a notice or other information respecting the modification to the device was not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k), and 21 CFR 807.81(a)(3)(i). The information your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Specifically, your firm made significant design changes to these devices, and did not submit a 510(k). For example, your firm modified the Integrated Fixation System. The performance of bone screws (e.g., maximum screw torque, screw retention strength) used to attach the Kelyniam Custom Skull Implant (CSI) to the native bone with (b)(4) is affected by bone screw and bone plate design features. The change from CSI fixation using bone plates and bone screws to CSI with Integrated Fixation System fixation using (b)(4) is an operating principle change which leads to the submission of a 510(k). Additionally, the Kelyniam Custom Skull Implant (CSI) is provided with 0.125” diameter pressure relief holes, equally spaced over the contour of the implant with 0.625” centerline spacing and a minimum of 0.500” edge margin. Kelyniam sales and marketing documentation describes CSI (b)(4) instead of pressure relief holes over the entire implant. The TSS implant with larger solid areas without (b)(4) than the cleared CSI may result in safety and effectiveness concerns regarding increased intracranial pressure resulting from fluid collection beneath the secured implant. CSI option #2 Temporal Suture System is an operating principle change which leads to the submission of a 510(k). Please refer to the guidance document entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device” for further insight.
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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. If the letter contains OAI charges under the Quality System regulation, include: Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations 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.
Your firm’s response should be sent electronically to: William C. MacFarland, Acting Director of Compliance Branch, at oradevices1actingdcb@fda.hhs.gov. Refer to the Unique Identification Number (CMS case #527408) when replying. If you have any questions about the contents of this letter, please contact: Stephanie Durso, District Compliance Officer, at 973-331-4911 or email at stephanie.durso@fda.hhs.gov.