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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Spinal Solutions, LLC 1/19/12

  

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

Public Health Service
Food and Drug Administration
 Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415 

 

WARNING LETTER


VIA UNITED PARCEL SERVICE


January 19, 2012

W/L 15-12


Roger Williams
President
Spinal Solutions, LLC
26157 Jefferson Ave.
Murrieta, California 92562


Dear Mr. Williams:
 

During an inspection of your firm located in Murrieta, California, on July 11, 2011, through September 15, 2011, investigators from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer because you are a repacker/kit assembler of spinal implant systems, and an own-label distributor of spinal implant instruments. 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR) Part 820. We received a response from Arnold Neves, Jr., Esq., General Counsel, dated September 29, 2011, concerning our investigators' 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. These violations include, but are not limited to, the following:


1. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).


For example: Your firm does not have any procedures for corrective and preventive actions (CAPA).


We reviewed your firm's response and conclude that it is not adequate. Your firm promised to correct the observation, but has not provided us with a CAPA procedure, evidence of its implementation, and evaluation of previous CAPA sources to determine if a CAPA should have been initiated.


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: Your firm does not have any procedures for control of nonconforming product or facilities for segregation of nonconforming product.


We reviewed your firm' s response and conclude that it is not adequate. Your firm promised to correct the observation, but has not provided us with a nonconforming product procedure, evidence of its implementation, and evaluation of previously-processed product to ensure that nonconforming product was not distributed without documentation of justification.


3. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR 820.198(a).


For example: Procedure 805, "Customer Complaints," does not identify who is responsible for the review and evaluation of complaints; who will determine whether complaint investigations are necessary and the methods used for that determination; and how complaints will be investigated.


We reviewed your firm's response and conclude that it is not adequate. The response indicates that Spinal Solutions will incorporate the individual manufacturers' complaint handling and MDR procedures into its own procedures and supplementing those procedures with additional requirements, but the response does not include any revised procedures, evidence of implementation, or evaluation of previous complaints to determine if an investigation is necessary.


4. 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.


For example:


a. Procedure 704, "Purchasing," indicates that all finished device manufacturers supplying product to your firm require a Supplier Agreement that defines product and quality system requirements. Your firm identified (b)(4) from which it currently receives kits and components, but your firm does not have quality agreements with 4 of the (b)(4) In addition:


i. The agreement with (b)(4) does not address complaint handling, medical device reporting, labels/labeling content, product recall, or maintenance of device history records.


ii. The agreement with (b)(4) does not address product design changes, complaint handling, medical device reporting, product recall, or maintenance of device history records.


iii. The agreement with (b)(4) does not address complaint handling and maintenance of device history records. Further, the term of the agreement expired on the third anniversary of the effective date.


iv. The agreement with (b)(4) does not address medical device reporting, product design changes, label content, and device history records. Also, the agreement expired six months after the effective date.


v. The agreement with (b)(4) does not address product design changes, complaint handling, medical device reporting, recalls, label/labeling content, or maintenance of device history records. Additionally, the agreement is not signed and dated.


We reviewed your firm's response and conclude that it is not adequate. Your firm indicated that it will revise its purchasing agreements with its suppliers to include provisions dealing with product design changes, complaint handling, medical device reporting, product recall, and maintenance of device history records. However, Spinal Solutions has not provided any new or revised purchasing agreements, reviews of any other suppliers to ensure that adequate supplier agreements exist, or investigations to ensure that there have not been any previous design changes of which your firm is unaware.


b. Procedure 704, "Purchasing," does not describe any quality requirements for Class I devices, such as manual surgical instruments, nor does it define the frequency with which evaluations are to be performed for suppliers, contractors, and consultants. In addition, the procedure requires your firm to maintain an Approved Suppliers List and evaluate suppliers prior to utilization of services, but the firm does not have an Approved Supplier List or records of evaluation of suppliers.


We reviewed your firm's response and conclude that it is not adequate. Your firm indicated that Procedure 704 will be revised to include requirements for Class I devices, but the response does not include any new or revised purchasing control procedures, including evidence of implementation, or evaluation of previously received Class I devices to ensure that the supplier was in compliance. In addition, the response does not address the observation as it pertains to the lack of an Approved Supplier List and records of evaluation of suppliers.


5. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d).


For example: Your firm has not developed any final acceptance specifications or release criteria for any of its products, does not document any final acceptance activities, and has no procedures for final acceptance activities.


We reviewed your firm's response and conclude that it is not adequate. Your firm indicates that final device acceptance procedures will be developed, but Spinal Solutions has not provided any such procedures, and it has not provided any evaluation of previously distributed product to ensure that it was adequately evaluated and approved.


6. Failure to establish and maintain adequate procedures for acceptance of incoming product, as required by 21 CFR 820.80(b).


For example: According to Procedure 705, "Receiving," (b)(4) receiving acceptance activities are to be documented on a receiving log and approval documented on the packing slip. However, your firm has not developed or maintained a receiving log, and (b)(4) Packing Slips (b)(4) and (b)(4)) and (b)(4) Packing Lists (b)(4), and (b)(4) do not contain a signature and date for acceptance.


We reviewed your firm's response and conclude that it is not adequate. Your firm promised to revise procedure 705 and develop a receiving log, but the response does not include that a new procedure, receiving log, or an evaluation of previously-received products to determine whether proper receiving acceptance activities were performed and that the received product was approved.


7. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.

For example: Your firm has not established a procedure for the performance of quality audits. In addition, your firm stated that it has had one internal audit conducted by your firm's FDA Compliance Consultant; however, the date of the audit was not documented.


We reviewed your firm's response and conclude that it is not adequate. Your firm promised to perform quality audits, but the response does not include any quality audit procedures or evidence of the performance of any quality audits.


8. Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of 21 CFR Part 820 and the manufacturer's established quality policy and objectives, as required by 21 CFR 820.20(c).


For example: Though your firm's Quality Manual, Revision A, (b)(4) states that management review is conducted twice each year, no management reviews have been documented.


We reviewed your firm's response and conclude that it is not adequate. In the response, Spinal Solutions promised to document management reviews, but the response does not include any evidence of the performance of any management reviews.


9. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b).
 

For example: Your firm has not defined or documented procedures for identifying training needs.


We reviewed your firm's response and conclude that it is not adequate. Spinal Solutions indicated that training manuals are in development, but the response does not include any training manuals, any procedures for identifying training needs, or evidence of the implementation of new training requirements.


10. Failure of management with executive responsibility to establish its policy and objectives for, and commitment to, quality, as required by 21 CFR 820.20(a).


For example: Though Quality Manual, Revision A, (b)(4) states the Spinal Solutions quality policy and quality objectives are to be periodically reviewed during management review and that the quality policy is to be posted throughout the facility, a quality policy and objectives have not been defined, documented, and implemented.


We reviewed your firm's response and conclude that it is not adequate. Your firm indicated that executive management will ensure implementation of quality requirements and will ensure that quality systems procedures are followed, but the response does not indicate that executive management will develop a quality policy and objectives and establish such a policy and objectives, or include evidence of the distribution of the firm's quality policy and objectives.


11. Failure of management with executive responsibility to appoint, and document the appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: (i) ensuring that quality system requirements are effectively established and effectively maintained in accordance with 21 CFR Part 820; and (ii) reporting on the performance of the quality system to management with executive responsibility for review, as required by 21 CFR 820.20(b)(3).


For example: Though Quality Manual, Revision A, (b)(4) identifies the QS&RA Department Manager as the Management Representative, Spinal Solutions does not have a QS&RA Department Manager and has not designated any other individual as a management representative.


The adequacy of your firm's response cannot be determined at this time. Your firm indicated that Spinal Solutions has appointed a management representative, but no evidence has been provided of such an appointment.


12. Failure to establish and maintain adequate procedures to control all documents that are required by 21 CFR Part 820, as required by 21 CFR 820.40.


For example: Your firm does not have a procedure designating an individual to review for adequacy and approve prior to issuance all documents established to meet the requirements of 21 CFR Part 820. In addition, Quality Manual, Revision A, (b)(4) was not approved.


We reviewed your firm's response and conclude that it is not adequate. The response indicates that Spinal Solutions will revise the Quality Manual to include document control requirements, but the response does not include a revised Quality Manual or evidence of implementation of document control requirements. In addition, your firm has not reviewed all other documentation to ensure that it is properly approved.


13. Failure to maintain device history records (DHRs), as required by 21 CFR 820.184. For example: Your firm does not document any information required in a DHR, nor does it have procedures to ensure that DHRs are maintained.


The adequacy of your firm's response cannot be determined at this time. The response indicates that Spinal Solutions has begun developing a procedure for maintaining DHRs and will begin creating DHRs for all new trays, but your firm has not provided any DHR procedures, including evidence of their implementation, or any method for determining any of the information that would have been documented in the DHRs of products that have already been distributed.


14. Failure to maintain device master records (DMRs), as required by 21 CFR 820.181.


For example: Your firm does not document any information required in a DMR.


We reviewed your firm's response and conclude that it is not adequate. The response indicates that Spinal Solutions has begun developing a procedure for maintaining DMRs and has created procedures for assembling trays and labeling, but your firm has not provided any DMR procedures, including evidence of their implementation, any documentation of specifications and quality assurance procedures, or any evaluation of previously-distributed kits to determine if they were produced using adequate processes.


Our inspection also revealed that your firm's devices are misbranded under Section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), in that the labeling for the devices fails to bear adequate directions for use for the purposes for which they are intended.


For example: Your firm did not provide package inserts for the spinal systems in its kits. Those package inserts are required in order to provide adequate directions for use.


The adequacy of your firm's response cannot be determined at this time. Your firm indicated that a copy of the label/Instructions For Use will be provided to the hospital with a set each time, but it has not provided any evidence of implementation of this corrective action. In addition, your firm has not provided any evidence of actions taken to ensure that devices that have already been distributed bare adequate instructions for use.


Our inspection also revealed that your firm's devices are misbranded under Section 502(f)(2) of the Act, 21 U.S.C. 352(t)(2), in that the labeling for the device fails to bear adequate warnings.


For example: Your firm did not provide package inserts for the spinal systems in its kits. Those package inserts include all of the warnings and contraindications associated with the spinal systems. Therefore, the device labeling does not bear adequate warnings without the package inserts.


The adequacy of your Firm's response cannot be determined at this time. Your firm indicated that a copy of the label/Instructions For Use will be provided to the hospital with a set each time, but it has not provided any evidence of implementation of this corrective action. In addition, your firm has not provided any evidence of actions taken to ensure that devices that have already been distributed bare adequate warnings.


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 (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:


Blake Bevill
Director, Compliance Branch
U.S. Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506


Refer to the Unique Identification Number 235836 when replying. If you have any questions about the contents of this letter, please contact Jessica Mu, Compliance Officer, at 949-608-4477.


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/
Alonza E. Cruse
District Director