WARNING LETTER
Vilex in Tennessee, Inc
MARCS-CMS 543749 —
January 09, 2018
Recipient:
Recipient Name
Ms. Sylvia J. Southard
Vilex in Tennessee, Inc
111 Moffitt St.
McMinnville
,
TN
37110
United States
Issuing Office:
Florida District Office
United States
Office of Medical Device and Radiological Health Operations (Division 2)
555 Winderley Place, Suite 200
Maitland, Florida 32751
WARNING LETTER
CMS # 543749
UNITED PARCEL SERVICE
w/DELIVERY CONFIRMATION
January 9, 2018
Ms. Sylvia J. Southard
President
Vilex in Tennessee, Inc.
111 Moffitt St.
McMinnville, Tennessee 37110
Dear Ms. Southard:
During an inspection of your firm located in McMinnville, Tennessee on August 16 through August 25, 2017, an investigator from the United States Food and Drug Administration (FDA) determined that your firm operates as a specification developer and relabeler/repacker, and conducts limited manufacturing operations, for your Class I and Class II orthopedic implants and tools. 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.
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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. You may find the Act and FDA’s regulations through links in FDA’s home page at
www.fda.gov
.
We received your response dated September 18, 2017, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Observations, which was issued to your firm on August 25, 2017.
We address this response below, in relation to each of the noted violations.  These violations include, but are not limited to, the following:
(1)
Failure to establish design history files, as required by 21 CFR 820.30(j). Specifically, your firm did not adequately document design history files  for the following Class II medical devices:
A.
Met-Head Implant (K070052)
B.
Vilex Bone Plate System (K041287)
C.
Talus of Vilex (TOV) (K041289)
D.
Cannulated Hemi Toe Implant (K023684)
E.
Dual Thread Bone Screw (K014154)
F.
Lag Screw – Titanium/Stainless (K991151)
G.
Lag Screw – Stainless (K991197)
H.
Cannulated Hemi Toe Implant – HA Coating (K973309)
We reviewed your firm’s response and acknowledge your commitment to correcting all violations noted during the most recent inspection. Additionally, you explain that some of your devices may have all of the documents required for a Design History File located in the 510(k) file. However, your response is inadequate in that you have not indicated which of your devices may have the documentation in the 510(k) file, what the existing documents actually are, or provide a listing of such documents. Additionally, you indicate that the Design History Files should be compiled by January 1, 2018, or at the latest March 15, 2018; however, you have not provided an update on whether these Design History Files are complete and CAPAs subsequently closed. An assessment of each Corrective and Preventive Action (CAPA) opened to document your corrective actions, along with an evaluation of the implementation of your planned corrective actions, will be reviewed during the next inspection.
(2)
Failure to adequately establish procedures for design validation, as required by 21 CFR 820.30(g). Your Design Verification and Validation (QSP 5.5, Rev E) procedure is not adequately implemented.
For example:
A.
The procedure requires design validation to be conducted according to an approved design validation plan and to pre-approved written protocols. The Protocol for Design Validation of Orthex External Fixation System is dated 1/17/2017. Design validation activities were completed between 12/26/2014 and 4/14/2015, two years before the validation protocol was approved.
B.
The procedure requires the validation results to include the identification of the design including the revision level, production stage, and/or model number if assigned. The drawing revision(s) and lots numbers for the hardware used in the design validation is not recorded in the Report for Design Validation of Orthex External Fixation System. Furthermore, product code R065-155 is misidentified as R100-065 and product code AS137-295 is misidentified as AST135-295 in the report.
We reviewed your firm’s response and acknowledge your commitment to correcting all violations noted during the most recent inspection. Further, you state that updates will be made to the Design Verification and Design Validation procedures will be updated. You also state that employees will receive training regarding new forms, as well as AAMI training. The Design History Files for all previous and current development projects will be reviewed and updated appropriately with the new procedural requirements. However, your response is inadequate in that you have not provided updated procedures, evidence of training, or the result of your review of previous and current Design History Files. An assessment of the Corrective and Preventive Action (CAPA) opened to document your corrective actions, along with an evaluation of the implementation of your planned corrective actions, will be reviewed during the next inspection.
(3)
Failure to adequately establish procedures to ensure that all purchased or otherwise received product or services conform to specified requirements, as required by 21 CFR 820.50. Specifically, your Purchasing Procedure (QSP6.1, Rev I) is not adequate. The procedure does not ensure that suppliers of critical processes that cannot be verified, such as sterilization, passivation, and hydroxyapatite (HA) coating, are evaluated on their ability to meet specified requirements. Your firm qualifies your suppliers based solely on ISO certification(s) and does not adequately document that each supplier can consistently produce devices in accordance with the designated specifications.
We reviewed your firm’s response and acknowledge your commitment to correcting all violations noted during the most recent inspection.  Further, you have committed to updating several procedures (i.e., Supplier Change Agreement, Purchasing, and Design Transfer), along with forms used in conjunction with those procedures. Additionally, your response indicates all supplier files will be updated to contain audit reports, surveys, NDAs, or supplier quality agreements by November 1, 2017. Retrospective control plans will be added to each Design History File by December 1, 2017. However, your response is inadequate in that you do not address training requirements related to updated procedures and forms. An assessment of each Corrective and Preventive Action (CAPA) opened to document your corrective actions, along with an evaluation of the implementation of your planned corrective actions, will be reviewed during the next inspection.
(4)
Failure to adequately document results of the design risk analysis, as required by 21 CFR 820.30(g). Specifically, you did not implement your Hazard Analysis and Risk Assessment Procedure (QSP 5.2, Rev D). According to this procedure, the need for risk mitigation for each identified hazard is determined by comparing a
(b)(4)
(calculated by
(b)(4)
) to values on the Risk Index table found on QSF5.2-5. The completed and approved risk assessments in the design history files for the Ultima Half Pin and Hammerfuze utilize a system where a Risk Priority Number (RPN) is calculated by
(b)(4)
. During the inspection your firm was unable to identify what the calculated RPN is compared to and whether risk mitigation is necessary.
We reviewed your firm’s response and acknowledge your commitment to correcting all violations noted during the most recent inspection. Further, your response indicates updates to several procedures (i.e., Risk Management, Document Change Control, and Design Transfer), along with all required training, will be completed by October 15, 2017. Your response also indicates a review of all existing Design History Files to ensure compliance with the new procedures will be completed by January 1, 2018.  However, your response is inadequate in that the updated procedures for document change controls and design transfer have not been provided for review. Additionally, the results of your review of all existing Design History Files has not been provided for review. An assessment of each Corrective and Preventive Action (CAPA) opened to document your corrective actions, along with an evaluation of the implementation of your planned corrective actions, will be reviewed during the next inspection.
(5)
Failure to document rework and reevaluation activities in the device history record, as required by 21 CFR 820.90(b)(2). Specifically, NCR #15-011 was opened to document
(b)(4)
of the product. The report states these pieces were reworked by
(b)(4)
. However, documentation of this rework, including retesting and reevaluation of the nonconforming product after rework to ensure that the product meets the current approved specifications and a determination of any adverse effect from the rework upon the product, were not documented in the Device History Record (DHR).
We reviewed your firm’s response and acknowledge your commitment to correcting all violations noted during the most recent inspection. Further, you have updated procedures and a form (i.e., Non-Conformance Procedure, Work Order Procedure, and Work Order Form) in response to this observation. Additionally, all personnel received training on the updated procedures and form was completed on September 5, 2017. However, your response is inadequate in that while you address this specific circumstance, you have not indicated a review of the system, and other potentially reworked products, was planned. An assessment of each Corrective and Preventive Action (CAPA) opened to document your corrective actions, along with an evaluation of the implementation of your planned corrective actions, will be reviewed during the next inspection.
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. 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.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions (which must address systemic problems) 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.  If you have questions regarding any issues in this letter, please contact Compliance Officer, Melissa Michurski at 612-758-7185 or at melisssa.michurski@fda.hhs.gov. Please send your reply electronically to Blake Bevill, Director of ComplianceBranch,
oradevices2firmresponse@fda.hhs.gov
.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s 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 close 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 bring the products into compliance.
Sincerely,
/S/
Kathleen Sinninger
Acting Program Division Director
Office of Medical Device and Radiological Health
Division 2 - Central
Content current as of:
03/20/2018