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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Shasta Technologies, LLC 4/8/14

  

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

Public Health Service
Food and Drug Administration
 
Seattle District
Pacific Region
22215 26th Ave SE, Suite 210
Bothell, WA 98021
Telephone:      425-302-0340
FAX:    425-302-0402

 

April 8, 2014
 
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
 
In reply refer to Warning Letter SEA 14-08
 
Calvin A. Knickerbocker II
President and Managing Member
Shasta Technologies, LLC
3257 Highway 128
Calistoga, California 94515
 
WARNING LETTER
 
Dear Mr. Knickerbocker:
 
During an inspection of your firm located at 16923 SW Richen Park Circle, Sherwood, Oregon, on December 2, 2013 through December 9, 2013, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the GenStrip Blood Glucose Test Strips. 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 this device is 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 you dated December 30, 2013, concerning our investigators’ observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to Mr. Calvin Knickerbocker III, your firm’s general counsel (responsible for regulatory operations and quality systems), on December 9, 2013. 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 (CAPA), as required by 21 CFR 820.100(a). Specifically, no corrective and preventive action procedures were available for review upon request by the investigator.  Mr. Calvin Knickerbocker III indicated that Shasta does not have CAPA procedures.
 
Your firm’s response is not adequate.  Your firm provided the Quality Manual Doc No. QS-1001, which states that Quality Manual Doc No. QS-1001 section 14.0 Corrective and Preventive Action describes the Shasta Technologies CAPA activities and that it relies on its contractor’s CAPA procedures because all manufacturing and distribution is performed by the contract manufacturers. However, this is not adequate because this does not specify your firm’s involvement or responsibility for the corrective and preventive action procedure. Your firm did not provide evidence of a procedure that describes analyzing the corrective and preventive action processes, investigating the cause of nonconformities relating to the product, verifying or validating the corrective and preventive action, implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems, ensuring that information related to quality problems is disseminated to those directly responsible for assuring the quality of the product, and submitting relevant information on identified quality problems and corrective and preventive actions for management review as required by the CAPA requirements of 21 CFR 820.100. Your firm did not provide evidence of a retrospective review of other procedures pertaining to the CAPA subsystem, such as complaint handling and nonconformance procedures, to ensure they were documented as required.
 
2.    Failure to maintain complaint files and to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically, no complaint handling procedures were available for review upon request by the investigator. Mr. Calvin Knickerbocker III indicated that Shasta does not have complaint handling procedures although he reviews consumer reviews on the internet and thus is conducting complaint handling activities for Shasta.
 
Your firm’s response is not adequate. You have stated that procedures for receiving, reviewing and evaluating complaints are maintained by your contract manufacturers. Your firm did not provide evidence of a procedure that describes how complaints are processed in a uniform and timely manner, how oral complaints are documented, how complaints are evaluated to determine whether the complaint should be reported to FDA under part 803, and how complaints are reviewed and evaluated to determine whether an investigation is necessary as required by 21 CFR 820.198(a). In addition, your firm has not provided evidence that the consumer reviews Mr. Calvin Knickerbocker III reviewed on the internet and any other complaints were documented as required by your firm’s complaint handling procedure.
 
3.    Failure to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).  Specifically, no design control procedures were available for review upon request by the investigator. The Genstrip Master Quality Plan, Revision A, release date September 19, 2013, indicates that Shasta is responsible for design controls for the GenStrip Blood Glucose Test Strips including “setting the product requirements”. Mr. Calvin Knickerbocker III indicated that Shasta does not maintain design records covering GenStrip Blood Glucose Test Strips.   
 
Your firm’s response is not adequate. Your firm has not provided design control procedures in its response. Additionally, your firm has not indicated that a retrospective review was completed of the GenStrip Blood Glucose Test Strips to ensure design controls were completed as required.
 
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. For example, no purchasing control procedures were available for review upon request by the investigator. Shasta contracts out manufacturing, marketing, and complaint handling for GenStrip Blood Glucose Test Strips. Specifically, your firm has indicated that contractors (b)(4) are responsible for document controls, purchasing controls, and CAPA, and that (b)(4) is responsible for handling complaints. However, your firm did not provide evidence that it has defined, documented, and implemented purchasing control procedures to describe how it controls services provided by these contractors. Mr. Calvin Knickerbocker III indicated that Shasta does not have purchasing control procedures. 
 
Your firm’s response is not adequate. Your firm provided a Quality Manual, dated effective as of December 31, 2013, which states that Shasta Technologies, LLC has established purchasing procedures; however, your firm has not provided evidence that it has implemented and maintained the purchasing controls procedure. Your firm did not provide evidence to demonstrate that purchasing control procedures ensured that all purchased or received product and services from the designated contractors met specified requirements. Additionally, your firm did not provide evidence of training on the new purchasing controls procedures and did not provide a copy of this procedure.
 
5.    Failure to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). For example, your firm does not maintain documented evaluation of suppliers and contractors it uses to conduct manufacturing, marketing, and complaint handling for GenStrip Blood Glucose Test Strips. Your firm does not maintain documented evaluation of activities that the contract manufacturer conducts, including process validation, nonconforming product, acceptance activities, labeling and packaging in the manufacture of GenStrip Blood Glucose Test Strips.  Mr. Calvin Knickerbocker III indicated that he would decline to provide the investigator documentation of contractor evaluation.
 
Your firm’s response is not adequate. You have stated that you are in the process of addressing the continued qualification of the contract manufacturers by participation in routine management review meetings and yearly internal audits that will be completed by February 28, 2014. However, you have not provided evidence of performing previous management reviews and internal audits of the suppliers and have not provided any evidence that you have established procedures to evaluate and select potential suppliers, contractors and consultants for the GenStrip Blood Glucose Test Strips as required by 21 CFR 820.50(a).  In addition, your firm did not provide evidence that specified the level of control over the contractors and the designated responsibilities, nor did your firm provide evidence that it has conducted a retrospective review of all suppliers to ensure that they were evaluated and selected as required.
 
6.    Failure to establish and maintain procedures to control all documents, as required by 21 CFR 820.40. Specifically, no document control procedures were available for review upon request by the investigator. Mr. Calvin Knickerbocker III indicated that Shasta does not have document control procedures. According to the Genstrip Master Quality Plan, Revision A, release date September 19, 2013, and signed by Mr. Knickerbocker, Shasta is responsible for document controls.
 
Your firm’s response is not adequate. Your firm has stated that it relies on its contract manufacturers for document control. However, this is not adequate because your firm did not provide evidence that it has established and maintained document control procedures as required by 21 CFR 820.40. Your firm did not provide evidence of a procedure that designates an individual to approve and distribute documents, or to review and approve changes to the documents. Additionally, your firm did not indicate that a retrospective review of all documents to ensure that they were controlled as required was performed.
 
7.    Failure to establish policy and objectives for, and commitment to, quality by the management with executive responsibility, as required by 21 CFR 820.20(a). Specifically, no quality policy was available for review upon request by the investigator.  Mr. Calvin Knickerbocker III indicated that Shasta does not have a quality policy.  According to the Genstrip Master Quality Plan, Revision A, release date September 19, 2013, Shasta has responsibility for Management Responsibility including a Quality Policy.
 
Your firm’s response is not adequate. Your firm has stated that a quality system policy exists and has been established with executive responsibility at the contract manufacturers. Additionally, your firm states that the Quality Manual Doc No. QS-1001 Section 1.0 Management Responsibility defines your firm’s management responsibility, quality policy, organizations, and responsibility and authority. However, your firm did not indicate that it conducted a retrospective review of the quality management system to ensure that all procedures were established as required and did not provide a copy of the quality policy and evidence that employees were trained on the policy.
 
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 this part and the manufacturer’s established quality policy and objectives, as required by 21 CFR 820.20(c). Specifically, no procedures for management review were available for review upon request by the investigator. Mr. Calvin Knickerbocker III indicated that Shasta does not have management review procedures.
 
Your firm’s response is not adequate.  Your firm has stated procedures for management review exist at the contract manufacturers and that your firm plans to participate in the contract manufacturer’s routine review of the quality procedures for the GenStrip Blood Glucose Test Strips manufacturing and distribution and that your firm plans to complete this by February 28, 2014, and it would ensure that these reviews were conducted as required.  However, this response is inadequate because your firm did not provide evidence that it established procedures to review the suitability and effectiveness of its quality system at defined intervals. In addition, your firm did not provide evidence that the management reviews were completed as required and that employees would be trained on the new procedures.
 
9.    Failure to establish quality system procedures and instructions, as required by 21 CFR 820.20(e). Specifically, no quality system procedures and instructions were available for review upon request by the Investigator. Mr. Calvin Knickerbocker III indicated that Shasta does not have quality system procedures. According to the Genstrip Master Quality Plan, Revision A, release date September 19, 2013, and signed by Mr. Knickerbocker, “Each company will maintain a quality system that is consistent with its project role.”
 
Your firm’s response is not adequate. Your firm provided a Quality Manual, dated effective as of December 31, 2013, that includes the title, scope of, applications, definitions, quality policy and objectives, and responsibilities for their quality system procedures; however, this manual was not signed by management. Additionally, your firm provided a Genstrip Master Quality Plan, Revision A, dated September 19, 2013; however, review of the Genstrip Master Quality Plan, Revision A does not specify how your firm has established and maintained quality system procedures and instructions, or how it has established controls over the procedures and instructions developed by contractors as required by 21 CFR 820.20(e). Additionally, your firm did not provide evidence that employees were trained on the provided procedure dated effective as of December 31, 2013.
 
10.    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:
 
  • No procedures for quality audits were available for review upon request by the investigator. Mr. Calvin Knickerbocker III indicated that Shasta does not have a quality audit procedure.
  • Quality audits have not been performed as indicated by Mr. Calvin Knickerbocker III.
 
Your firm’s response is not adequate. Your firm has stated that the Quality Manual Doc No. QS-1001 Section 4.0 Design Control was prepared to comply with the QS regulation requirements and that it relies on the design control procedures of the contract manufacturers. However, your firm has not provided evidence that it has established and maintained procedures to conduct quality audits to assure that the quality system is in compliance with established quality system requirements and to determine the effectiveness of the quality system. Additionally, your firm has not provided evidence that quality audits have been conducted by your firm as required. In addition, your firm did not provide evidence that a retrospective review of the quality system was conducted to ensure that all procedures were established as required by 21 CFR 820.
 
11.    Failure to maintain a device master record (DMR), as required by 21 CFR 820.181. Specifically, no DMR was available for review upon request by the investigator. Mr. Calvin Knickerbocker III indicated that Shasta does not maintain a DMR for GenStrip Blood Glucose Test Strips and that he declines to provide the investigator with the DMR during this inspection.
 
Your firm’s response is not adequate. Your firm has stated that it relies on its contract manufacturers for the device master record. However, this is not adequate because your firm is responsible for maintaining this information in a manner that is available for review. Additionally, your firm did not provide a copy of the DMR for the GenStrip Blood Glucose Test Strips and evidence that it completed a retrospective review to ensure that DMRs were maintained as required by 21 CFR 820.181.
 
This inspection also revealed that your GenStrip Blood Glucose Test Strips labeled for use with LifeScan One Touch Ultra, Ultra2, and UltraMini blood glucose meters “purchased before July 2013” 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 device is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency.  [21 CFR 807.81(b)]  The kind of information that 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.
 
Additionally, the inspection revealed that your firm’s GenStrip Blood Glucose Test Strips are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:
 
Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example, written MDR procedures were not available for review upon request by the investigator.
 
Your firm’s response is not adequate. Your firm has stated that MDR procedures have been developed, maintained and implemented by the contract manufacturers. Additionally, you have stated that the Quality Manual Doc No. QS-1001 Section 14.0 Corrective and Preventative Action describes your complaint and MDR handling.  However, your firm did not provide evidence that it has developed, maintained, or implemented a written MDR procedure, nor did your firm indicate that it performed a retrospective review of adverse events to ensure that they were reported as required. 
 
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.
 
Your firm’s response should be sent to: Patricia A. Pinkerton, Compliance Officer, U.S. Food and Drug Administration, Seattle District Office, 22215 26th Ave SE, Suite 210, Bothell, Washington 98021. Refer to WL SEA 14-08 when replying. If you have any questions about the contents of this letter, please contact: Patricia A. Pinkerton, Compliance Officer at 425-302-0428.
 
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 yours,
 /S/                                                                                            
Ann M. Adams, PhD
Acting District Director
 
 
cc:   Mr. Calvin A. Knickerbocker III
        Shasta Technologies, LLC
        16923 SW Richen Park Circle
        Sherwood, Oregon 97140-8682                         
 
 
cc:    Dr. Yeung Yu
        Shasta Technologies, LLC
        5731 Dimas Court
        Pleasanton, California 94566
 
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