Inspections, Compliance, Enforcement, and Criminal Investigations

Spine Smith Holdings, LLC 4/3/13


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128 


April 3, 2013
Ref: 2013-DAL-WL-035
Kevin Dunworth, CEO and Founder
Spine Smith Holdings, LLC
93 Red River Street
Austin, Texas 78701
Dear Mr. Dunworth:
During an inspection of your firm located in Austin, Texas, on January 17 through 31, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm (a specification developer) manufactures cervical and lumbar interbody fusion systems and associated surgical instruments, such as CIMPLICITY™, VisuALIF®, IN:C2™, and Cynch™. 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.
We received a response, dated February 13, 2013, from Clifton (Chris) Naivar, Director, Quality and Regulatory Affairs, responding to our investigators' observations noted on the Form FDA 483 (FDA 483), List of lnspectional Observations that was issued to your firm. We reviewed your firm's response and note that it lacks sufficient corrective actions. We address your response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
Quality System (QS) Regulation
1.    Failure to establish and maintain adequate procedures for validating the device design to ensure that the devices conform to defined user needs and intended uses. The design validation shall include testing of production units under actual or simulated use conditions, and the design validation results shall be documented in the design history file (DHF), as required by 21 CFR 820.30(g).
Specifically, your firm's design validation results do not include testing of multiple (b)(4) sterilization cycles to determine their effects on the form, fit, and function of your implant devices using (b)(4) material. Your firm has not determined a worst case number of repeat (multiple) (b)(4) sterilization cycles to be performed by (b)(4) facilities until they exhaust all implants in instrument cases. Instrument cases could be continuously refilled for additional implants or implant sizes without exhausting the remaining implants.
Your response stated that multiple (b)(4) sterilizations were originally determined to have no effect on the raw (b)(4) material from the material supplier. However, you have not provided their study and your validation results to confirm whether or not repeat (b)(4) sterilization cycles have any impact on the fit, form, and functions for all finished implant devices referenced above. Your response further stated that your firm has initiated CAPA (b)(4) to evaluate a proper course of action and execute any additional simulated sterilization cycles and testing for all affected (b)(4) devices. You have not provided a timeframe for completing these activities.
2.    Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
Specifically, your firm did not conduct and document a risk evaluation as required by your CAPA Procedure (b)(4) when you received the following product complaints that have the potential to affect health, and initiate corrective actions to correct non-conforming products:
•    CAPA (b)(4) initiated on 1/20/10 reported that a Loose Graft Delivery Funnel broke at the weld between the shaft and the funnel during surgery. Your firm subsequently removed the remaining bone funnels in your inventory for rework (b)(4). The contract manufacturer changed the welding process from a (b)(4) weld to a (b)(4) weld to correct the issue.
•    CAPA (b)(4) initiated on 1/20/10 reported two (b)(4) implants from lot (b)(4) were found in the field without tantalum markers. On 12/15/09 a complaint for Lot (b)(4) was received from a physician for missing tantalum markers. Your firm re-inspected the inventory of these lots and subsequently revised inspection procedures used by your firm and contract manufacturer.
Your response stated that a review of the associated risk management file indicated that the failure mode for Complaint (b)(4) was documented in the "system risk analysis, (b)(4)," but was not referenced in the CAPA documentation. Your response has not provided the system risk analysis file for our review. Additionally, please advise if you have conducted a risk evaluation for Complaint (b)(4). Your response has also not provided a timeframe for completing your review of all CAPAs initiated in 2012, product complaints, and product non-conformances to identify if there are any missing risk evaluations, and whether or not missing risk evaluations could impact corrective actions.
3.    Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
Specifically, your firm has not established adequate complaint handling procedures for documenting and investigating complaints. For example:
•    13 of the 42 complaints received in 2010 and 2011 did not always document the name, address, and phone number of the complainants. See Complaint (b)(4).
•    The investigations for the 13 complaints were not conducted or documented approximately one year after the complaints were received.
Your response has not provided complaint handling procedures that define specific timeframes for documenting and investigating non-MDR reportable complaints and MDR reportable complaints, and for tracking the status of complaint investigations. Your response indicated that you initiated a Quality System Improvement Plan in December 2011 to address a large backlog of open complaints, that your review of 93 complaints was completed at the end of 2012, and that these complaints were investigated, updated, and closed with quality approval. Please explain whether your retrospective review of all complaints received since 2010 identified any MDR reportable events that must be reported to FDA under 21 CFR 803.
4.    Failure to establish and maintain procedures for quality audits and conduct such audits to assure that the quality system is in compliance with established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.
Specifically, your firm failed to conduct quality audits (b)(4) as required by your internal audit procedure, (b)(4), effective 1/9/08. The first quality audit was conducted on (b)(4), and the next quality audit was conducted on (b)(4), approximately (b)(4) later.
Your response stated that you hired a new Quality and Regulatory Affairs Director in first quarter of (b)(4), that because your Quality System Improvement Plan initiated in December 2011 would take all 2012 to implement, you arranged for a (b)(4) audit to be conducted in (b)(4) to provide objective evidence of effectiveness. If your (b)(4) audit has been in fact conducted, please identify the (b)(4) auditor(s) and the audit dates.
5.    Failure to establish and maintain adequate 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 firm has not evaluated and documented the ability of the contract manufacturers to meet specified requirements, including quality requirements.
Your response stated that your Quality System Improvement Plan initiated in (b)(4) found that the procedure for evaluation and approval of suppliers had not been released, supplier files were incomplete, and the list of approved suppliers was out of date, that you hired qualified personnel to perform supplier qualifications and audits starting (b)(4), and that you were developing a training program to qualify additional employees to perform supplier audits. Your response has not provided documentation that demonstrates your firm has in fact evaluated and selected the contract manufacturers of your implants and surgical instruments per your Supplier Evaluation Approval and Registration Procedure, (b)(4), effective 3/2/12, referenced in your response.
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 Ill 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 (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: Thao Ta, Compliance Officer, Dallas District Office, U.S. Food and Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the contents of this letter, please contact Mr. Ta at 214-253-5217.
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 lnspectional 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.
Reynaldo R. Rodriguez, Jr.
Dallas District Director 

Page Last Updated: 10/14/2015
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