Inspections, Compliance, Enforcement, and Criminal Investigations

Lusys Laboratories, Inc. 9/30/15

  

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
SIGNATURE REQUIRED                                                                                                            
 
 
September 30, 2015
WL # 38-15
Dr. Edward W. Lu
President/CEO
Lusys Laboratories, Incorporated
10054 Mesa Ridge Court, Suites 118-120
San Diego, CA 92121-2946       
                                                                       
Dear Dr. Lu:
 
During an inspection of your firm located in San Diego, California, on January 26 through February 19, 2015 and May 12 through May 15, 2015, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures in-vitro diagnostic test kits. Specifically, the test kits you manufacture include, but are not limited to, tests for qualitative detection of Hepatitis C Virus, Hepatitis B Virus, Hepatitis B “e” Antigen, Hepatitis B “s” Antibody, Human Immunodeficiency Virus, Types I and II Antibodies, Prostate Specific Antigen in human blood/serum/plasma and Ebola Virus (Ebola Virus VP/GP IgX One Step Test Kits, Ebola Virus GP-VP IgS type One-Step Test Kit, and the Ebola Virus Antigen Nasal One-Step Test Kit). 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 devices manufactured by your firm such as the One Step HCV Test Serum/Plasma/Blood Test, HBV 5 in 1 One Step Serum/Plasma Test, HBsAg For the One-Step Detection of Hepatitis B in Serum/Plasma, HIV (Separated) 3-Line One Step Detection Test of HIV Antibodies Blood/Serum Plasma Tests, and EQ-PSA One-Step Blood/Serum/Plasma Test that were exported are adulterated within the meaning of section 501(h)[21 U.S.C. § 351(h)] of the Act, 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 (CGMP) requirements for devices which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations 21 CFR, Part 820. Conformity to the CGMP requirements set forth in 21 CFR, Part 820  is a requirement to legally export such devices under Section 802(f)(1) of the Act [21 U.S.C. § 382(f)(1)].
 
We received a response from you, dated, March 3, 2015, concerning our investigators’ observations noted on the Form FDA 483 (FDA 483) List of Inspectional Observations that was issued to your firm on February 19, 2015. 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 has not established corrective and preventive action (CAPA) procedures which analyze quality data to identify existing and potential causes of nonconforming product or other quality problems, using appropriate statistical methodology.
 
Your firm has no procedures to:
• Investigate the cause of nonconformities.
• Identify actions needed to correct and prevent recurrence of nonconforming product or other quality problems.
• Verify and validate corrective and preventive actions.
• Implement and record changes necessary to correct and prevent identified quality problems.
• Disseminate information related to quality problems and nonconforming            
• Submit relevant information for management review.
 
When asked by the investigator to provide your firm’s procedures for implementing corrective and preventive actions, no documents were provided.
 
Your response dated 03/03/2015 is not adequate. You responded that “A robust and detailed Corrective and Preventive Action (CAPA) procedure will be drafted to ensure all quality events are thoroughly investigated and proper risk mitigation plans are put in place to prevent reoccurrence of nonconformities”. Your firm did not, however, submit any documentation or provide evidence of establishing and maintaining CAPA procedures. In addition, your firm did not provide evidence of implementation of a corrective action to include a retrospective review of all nonconforming product or procedures for investigating its nonconforming IVD devices to ensure they were documented as required. In addition, no date was provided for when corrections associated with this observation would be resolved.
 
2)    Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). For example:
 
a)    Your firm has not established procedures for conducting process validations.
 
b)    Your firm has not adequately established process validations associated with the assembly process, to include preparing (b)(4) or packaging for any of its IVD tests.
 
c)    Your firm could not provide documentation demonstrating that the (b)(4) brand sprayers are qualified to consistently dispense an adequate amount of product on the IVD test membranes.
 
d)    Your firm has no documented validation activities to challenge possible contamination during hand assembling operations. As an example, an employee was observed assembling HBV cassettes (Lot (b)(4)) and touching the coated membranes with bare hands.
 
The investigator asked your firm to provide all process validations that had been performed for the assembly process of its IVD tests, to (b)(4) and device packaging. Your firm did not provide these process validations.
 
Your firm's procedure, Process Control, QSP06, Revision A, date issued 07/15/05, states in section 4.2.1 that validation protocols are first drafted, reviewed, and signed before performing validation activities. Validation involves installation, operation and/or performance of the process or equipment. The validation is performed according to the protocol and signed off by the pertinent departments and QC/QA before any critical steps or control parameters are implemented. The validation activities are then to be documented.
 
In addition, your firm has not qualified the (b)(4) brand sprayers that are used to dispense (b)(4) onto the membrane sheets. Your firm's procedure, Process Control, QSP06, Revision A, date issued 07/15/05, states in section 4.7.1 that all equipment must be validated prior to initial use in the production process, after an equipment repair, or equipment relocation.
 
Your response dated 03/03/2015 is not adequate. You responded your firm “will conduct retrospective process validations in accordance with pre-approved protocols to ensure all steps in the manufacturing process can be fully verified by subsequent inspection and test” and “all employees conducting manufacturing operations will be retrained on proper gowning and Personal Protective Equipment (PPE) requirements. In addition, the manufacturing equipment listed will be qualified to ensure repeatability and accuracy in their performance”. Your firm did not, however, submit any documentation or provide evidence of establishing and maintaining validation plans or process validation procedures of its IVD devices including devices for HCV, HBV, HIV I/II, and PSA. Your firm also did not provide evidence of implementation of a corrective action to include a retrospective review of all devices requiring process validation or procedures for process validation to ensure they were documented as required. In addition, no date was provided for when corrections associated with this observation would be resolved.
 
3)    Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements were met, as required by 21 CFR 820.30(a). For example:
 
Your firm could not provide any Design Control procedures and has not conducted stability studies to support expiration dates for its finished IVD tests including the HIV (Separated) 3-Line One Step Detection Test of HIV Antibodies Blood/Serum Plasma Tests, One-Step HAV–IgG/IgM Serum/Plasma Test, HBV 5 in 1 One-Step Serum/Plasma Test, or the HBsAg For the One-Step Detection of Hepatitis B in Serum/Plasma test One-Step HCV Test Serum/Plasma/Blood Test. When asked by the investigator for the firm to provide Design Control procedures for the Class II and Class III devices that it manufactures, including the HIV (Separated) 3-Line One Step Detection Test of HIV Antibodies Blood/Serum Plasma Tests, One-Step HAV–IgG/IgM Serum/Plasma Test, HBV 5 in 1 One-Step Serum/Plasma Test, or the HBsAg For the One-Step Detection of Hepatitis B in Serum/Plasma test One-Step HCV Test Serum/Plasma/Blood Test, no documents were provided.
 
In addition, you indicated to the investigator that all products manufactured by your firm have an 18 month shelf life. The investigator also asked your firm to supply the stability studies to support this claim; however, the documents were not provided.
 
Your response dated 03/03/2015 is not adequate. You responded that “A robust and detailed design control procedure will be drafted to ensure we are in compliance with the 21 CFR 820.30 requirements”. Additionally, your firm stated that it has conducted accelerated stability studies on its products and that it is in the process of formalizing the data into its technical specifications documents to further support its expiration dating claims. Your firm did not, however, submit any documentation or provide evidence of establishing and maintaining procedures for Design Controls for the IVD products (e.g. HIV I/II, HAV, HBV and HCV) that are manufactured and distributed. Furthermore, your firm did not provide evidence of implementation of a corrective action to include a retrospective review of all devices requiring design controls to ensure they were documented as required.
 
In addition, upon request by the investigator, your firm did not provide any design plans or procedures for design and development activities for any of your Class II or Class III IVD devices including the following:
 
a.  HIV (Separated) 3-Line One Step Detection Test of HIV Antibodies Blood/Serum Plasma Tests HCV In-vitro Diagnostic Test
b.  One-Step HCV Test Serum/Plasma/Blood Test
c.  HBsAg For the One-Step Detection of Hepatitis B in Serum/Plasma
d.  HBV 5 in 1 One-Step Serum/Plasma Test
e.  One-Step HAV–IgG/IgM Serum/Plasma Test
 
Your response dated 03/03/2015 is not adequate. You responded that in conjunction with your firm’s plan to conduct retrospective process validations for its products, design plans will be established for the devices being manufactured (e.g. HIV I/II, HCV , HBV and HAV). Your firm did not, however, submit any documentation or provide evidence of establishing and maintaining design plans or procedures for design and development activities of the IVD devices listed in the above example. In addition, your firm did not provide evidence of implementation of a corrective action to include a retrospective review of all devices requiring design plans or procedures for design and development activities to ensure they were documented as required. In addition, no date was provided for when corrections associated with this observation would be resolved.
 
4)    Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example:
 
a)    Your firm did not establish procedures to ensure that complaints are evaluated to determine whether the complaint represents an event that is required to be reported to FDA, under Medical Device Reporting. Specifically, complaint ref no: (b)(4) received on 09/03/2014 for a HCG Combo Dipstick, Lot SEF087846, denotes under the problem description section "weak c-line and t-line" and "flow is slow." There was no evaluation to determine if this event  was MDR reportable; the Complaint Record form does not document this evaluation, and your firm’s procedure for handling complaints, Complaint and Technical Inquiries, QSP 11, Revision A, does not require this evaluation.
 
b)    Your firm has not documented and evaluated all complaints received by customers. For example, a complaint received from a customer, (b)(4) on a Purchase Order ((b)(4), dated 9/15/2014) states, "please, check the quality in HIV…I have a lot of customers angry with the results ... please be [careful]ly." This complaint was not documented or evaluated by your firm.
 
c)    Your firm has not documented complaints on the Customer Complaint Log, Technical Inquiry Log, or Complaint and Technical Inquiries Form as required by your firm’s QSP 11 procedure. Your firm only had one documented complaint; Complaint ref no: (b)(4) received on 09/03/2014. This complaint was documented on a “Product Complaint Form”,  which is not mentioned or referenced in the QSP 11 procedure; consequently, your firm is not following its own procedure.
 
Your response dated 03/03/2015 is not adequate. You responded you will be revising Standard Operating Procedure QSP11, “Complaint and Technical Inquiries”, to further define responsibilities and ensure complaints are reviewed by the appropriate personnel to include the quality unit.” Your firm did not, however, submit any documentation or provide evidence of establishing and maintaining complaint files or procedures for receiving, reviewing, and evaluating complaints for its IVD devices including devices for HIV I/II, HCV, HBV and HAV. In addition, your firm did not provide evidence of implementation of a corrective action to include a retrospective review of all device complaints or procedures for receiving, reviewing, and evaluating complaints for its IVD devices to ensure they were documented as required. In addition, no date was provided for when corrections associated with this observation would be resolved.
 
5)    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:
 
Your firm has not documented or implemented the evaluation of suppliers per the requirements in your firm’s SOP, QSP04 “Purchasing Control”, Revision A, no date of issuance.
 
Specifically, the procedure states in section 4.2.1 that all suppliers of goods and services including contractors, sub-contractors, and consultants are evaluated before issuing a purchasing data. The evaluation may be very simple such as having a potential supplier complete the Supplier Evaluation Form. Section 4.2.4 of the procedure, states that the evaluation of potential supplier is documented and maintained as part of the quality records.
 
Your firm was asked to provide Supplier Evaluation forms for the IVD devices it manufactures including devices for HIV I/II, HBV and HCV. Your firm stated that it has not utilized this form for any of its suppliers.
 
Section 4.3.2 of the procedure, notes that where applicable, documents such as the product specification and quality requirements are indicated on the purchase order or attached. The purchasing data shall also stipulate that the supplier agrees to [notify] Lusys Laboratories, Inc. of any changes made to the product and/or terms of the service so that Lusys may determine whether the change may [affect its] final products.
 
When asked by the investigator, your firm stated it has not documented product specification and/or quality requirements for product received from its suppliers nor does it have any purchasing agreements with any of its suppliers.
 
Your response dated 03/03/2015 is not adequate. You responded that “A formal supplier qualification procedure will be drafted to ensure all materials and services meet Lusys quality specifications”. Your firm did not, however, submit any documentation or provide evidence of establishing and maintaining procedures to ensure that all purchased or otherwise received product and services conform to specified requirements for its IVD devices including devices for HIV I/II, HBV and HCV. Your firm also did not provide evidence of implementation of a corrective action to include a retrospective review of the purchasing control procedures to ensure product specification and/or quality requirements are documented as required. In addition, no date was provided for when corrections associated with this observation would be resolved.
 
6)    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 established and maintained procedures for finished device acceptance to ensure that each lot of finished device meets acceptance criteria. Furthermore, your firm has not ensured that finished devices are not released for distribution until the activities, including acceptance activities, required by the Device Master Record are completed, the associated data and documentation is reviewed, and the authorization is dated.
 
Specifically, your firm uses a Routing Sheet to document final acceptance activities.
 
The Routing Sheets for Manufacturing Order No. 7823 --HCV, Lot AUI227823 and HAV IgM, Lot AUI777823, QC tested on 08/12/2014 do not clearly document the acceptance activities performed and the results of the tests. The tests were distributed in interstate commerce on 08/15/2014.
 
Your firm's procedure, Acceptance Activities- Receiving, In-process, and Finished Goods, QSP01, Revision A, date issued 07/15/05, states in section 4.4.1 that the specifications for the release of manufactured finished product are included in the SOP for releasing "In-process (sub-assemblies) and Finished Product." The investigator asked for this document, however, your firm was unable to provide it since it has not established this QC release SOP.
 
Your response dated 03/03/2015 is not adequate. You stated your firm “will further develop the appropriate release specifications for our products and maintain all manufactured product in a quarantine status until all applicable data has been reviewed and approved by the quality unit”. You did not, however, submit any documentation or provide evidence of establishing and maintaining finished device acceptance of its IVD devices including devices for HIV I/II, HBV, HAV, and HCV. You also did not provide evidence of implementation of a corrective action to include a retrospective review of all devices requiring finished device acceptance or procedures to ensure they were documented as required. In addition, no date was provided for when corrections associated with this observation would be resolved.
 
7)    Failure to establish and maintain procedures to adequately control environmental conditions where these conditions could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(c). For example:
 
Your firm has not established and maintained procedures to adequately control environmental conditions that could reasonably be expected to have an adverse effect on product quality, such as humidity. Furthermore, your firm has not established and maintained procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality.
 
Your firm's procedure, Process Control, QSP06, Revision A, issued 07/15/05, states under section 4.3.1 that appropriate environmental controls are established and monitored where variation in the environmental conditions could adversely affect the product, i.e., humidity and temperature control, environmental cleaning and maintenance. Your firm has not established and maintained procedures to control environmental conditions, such as humidity.
 
Your firm stated that it keeps the humidity set at (b)(4), since high humidity affects your product (e.g. H. pylori (feces), hCG, and HBV devices). The only environmental control your firm has consists of three dehumidifiers located in the dry room where all IVD test kits are assembled and packaged.
 
Your response dated 03/03/2015 is not adequate. You responded that “Appropriate levels of control will be established to ensure the environment is suitable for manufacturing and recorded appropriately. Procedures will be drafted to ensure proper maintenance and cleaning of processing equipment is completed and appropriate housekeeping activities are conducted within the manufacturing zones to prevent cross contamination. In addition, a defined line clearance procedure will be drafted to ensure the quality unit verifies appropriate segregation of all materials during production runs”. Your firm did not, however, submit any documentation or provide evidence of establishing and maintaining production and process controls of its IVD devices including devices for H. pylori (feces), hCG, and HBV devices. Your firm also did not provide evidence of implementation of a corrective action to include a retrospective review of all devices requiring environmental controls or procedures to ensure they were documented as required. In addition, no date was provided for when corrections associated with this observation would be resolved.
 
8)    Failure to establish and maintain procedures to adequately prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality as required by 21 CFR 820.70(e). For example:
 
The investigator observed employees handling coated membranes with bare hands and packaging them in plastic cassettes on tables in the packing room. Your firm was asked for cleaning procedures, showing how tables are to be cleaned between packaging of different products, however, they were not provided.
 
Your response dated 03/03/2015 is not adequate. You responded that “all employees conducting manufacturing operations will be retrained on proper gowning and Personal Protective Equipment (PPE) requirements”. Your firm did not, however, submit any documentation or provide evidence of establishing and maintaining production and process controls of its IVD devices including devices for H. pylori (feces), hCG, and HBV devices. Your firm also did not provide evidence of implementation of a corrective action to include a retrospective review of all devices requiring contamination controls or procedures to ensure they were documented as required. In addition, no date was provided for when corrections associated with this observation would be resolved.
 
9)    Failure to maintain device master records (DMR’s), as required by 21 CFR 820.181. For example:
 
Your firm stated that devices are manufactured using data recorded in laboratory notebooks. Your firm has not maintained device master records that include or refer to the location of device specifications, production process specifications, quality assurance procedures and specifications, and packaging and labeling specifications for the following devices:
 
            a.  HIV (Separated) 3-Line One Step Detection Test of HIV Antibodies Blood/Serum PlasmaTests HCV In-vitro Diagnostic Test
            b.  One-Step HCV Test Serum/Plasma/Blood Test
            c.  HBsAg For the One-Step Detection of Hepatitis B in Serum/Plasma
            a.  HBV 5 in 1 One-Step Serum/Plasma Test
 
The investigator asked for the DMRs associated with the all of your devices. Your firm stated that they were recorded in laboratory notebooks kept by Dr. Lu (President/ CEO). The investigator asked to see the laboratory notebooks. The data in the laboratory notebooks was not provided.
 
Your response dated 03/03/2015 is not adequate. You responded that “In conjunction with our plan of conducting retrospective process validations for our products, Master Device Records will be established for the listed products”. Your firm did not, however, submit any documentation or provide evidence of establishing and maintaining DMRs for its IVD devices. Your firm also did not provide evidence of implementation of a corrective action to include a retrospective review of all devices requiring DMRs or procedures to ensure they were documented as required. In addition, no date was provided for when corrections associated with this observation would be resolved.
 
10)    Failure to establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part, as required by 21 CFR 820.20(b). For example:
 
Your firm has not provided an adequate structure of resources, including the assignment of trained personnel for the management, for performance of work, and for internal quality audits and other assessment activities. Specifically, your firm does not have any individual dedicated to overseeing the Quality System.
 
The investigator asked your firm to address the organizational structure with regard to responsibilities and authority, resources, and management representatives. Your firm provided the “Lusys Laboratories, Inc. Organizational Chart” with the following explanation (b)(4) 
 
Your response dated 03/03/2015 is not adequate. You responded that “A more formal organizational structure will be established to clearly define roles and responsibilities. A clearly defined independent quality unit will be established to ensure processes are conducted in a compliant manner. In addition, a formal training procedure will be drafted to outline the required training and experience needed for perform individual tasks to include internal quality audits”. Your firm did not, however, submit any documentation or provide evidence of establishing and maintaining an organizational structure to ensure its IVD devices are designed and produced in accordance with the requirements of this part. Your firm also did not provide evidence of implementation of a corrective action to include a retrospective review of the organizational structure or procedures to ensure it is documented as required. In addition, no date was provided for when corrections associated with this observation would be resolved.
 
11)    Failure of management with executive responsibility to review the suitability 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, as required by 21 CFR 820.20(c). For example:
 
Your firm has not held or documented any periodic management review meetings. Your procedure for management review, QSP01, “Management Review Procedure”, Revision A, dated, 7/15/2005 requires (b)(4) management reviews.
 
Specifically, Section 4.1 of QSP01 states that the management reviews are held periodically, but at a minimum, (b)(4) review is held and section 4.4 indicates that management review meetings are documented as part of the quality records in support of the quality system and that attendance and minutes of the meeting are recorded. In addition, Section 4.4 further states that each manager is responsible for establishing trend reports or gauges in their area(s) of responsibilities and that at least (b)(4) during the management review meeting, such trend reports or gauges shall be presented and used to assess the total effectiveness of the quality system.
 
The investigator asked your firm to provide documentation that management reviews of the quality system had been performed with respect to the medical devices your firm manufactures. Your firm could not provide any documentation and stated that it has not conducted any reviews that include trend reports or analysis for any of your medical device products.
 
Your response dated 03/03/2015 is not adequate. You responded that “the listed procedure will be revised to further clarify management review responsibilities”. Your firm did not, however, submit any documentation or provide evidence of establishing and maintaining procedures to review the suitability and effectiveness of the quality system for any of the IVD devices it manufactures. Your firm also did not provide evidence of implementation of a corrective action to include a retrospective review of the management review procedures to ensure reviews are documented as required. In addition, no date was provided for when corrections associated with this observation would be resolved.
 
12)    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:
 
Upon request by the investigator, your firm did not provide a procedure for conducting Quality Audits. Your firm stated that no internal or third party quality audits had been conducted by the firm.
 
Your response dated 03/03/2015 is not adequate. You responded that “A procedure outlining how internal quality audits are to be performed will be drafted.” Your firm did not, however, submit any documentation or provide evidence of establishing and maintaining procedures for conducting quality audits for any of the IVD devices it manufactures. Your firm also did not provide evidence of implementation of a corrective action to include a retrospective review of all devices requiring quality audit procedures to ensure they were documented as required. In addition, no date was provided for when corrections associated with this observation would be resolved.
 
13)    Failure to establish and maintain procedures to control all documents that are required by this part, as required by 21 CFR 820.40. For example:
 
a)  Your firm’s procedure titled, Document Control, QSP03, Revision A, date issued 07/15/05, states that for level one and two documents, at least three individuals’ approval is required and for level three documents, two approval signatures are required.
 
Both the review and approval processes are to be documented, however, the procedure does not define what each level means.
 
b) The following documents were observed to be used, but were not approved through your document control process:
 
•  Product Complaint Form (used to document complaints).
•  Routing Sheet (used to document QC activities)
 
These documents are not associated with any SOP provided and reviewed by the investigator and there was no evidence that either document was approved through the document control process outlined in QSP03.
 
Your response dated 03/03/2015 is not adequate. You responded that “The overall document control procedure will be revised to further define roles and responsibilities to ensure compliance with 21 CFR 820.40”. Your firm did not, however, submit any documentation or provide evidence of establishing and maintaining document control procedures for any of the IVD devices it manufactures. Your firm also did not provide evidence of implementation of a corrective action to include a retrospective review of the document control procedures to ensure documents are approved with appropriate signatures and dates as required. In addition, no date was provided for when corrections associated with this observation would be resolved.
 
Our inspection also revealed that the in-vitro diagnostic devices your firm manufactures and commercially distributes, such as the Ebola Virus VP/GP IgX One Step Test Kits, Ebola Virus GP-VP IgS type One-Step Test Kit, Ebola Virus Antigen Nasal One-Step Test Kit, One Step HCV Test Serum/Plasma/Blood Test, HBV 5 in 1 One Step Serum/Plasma Test, HBsAg For the One-Step Detection of Hepatitis B in Serum/Plasma, HIV (Separated) 3-Line One Step Detection Test of HIV Antibodies Blood/Serum Plasma Tests, EQ-PSA One-Step Blood/Serum/Plasma Test, Toxoplasma One-Step Serum/Plasma Test IgG, Toxoplasma One-Step Serum/Plasma Test IgM, H. pylori IgG ELISA Kit - (96 Tests), H.pylori Antigen (Feces) One-Step Detection of Helicobacter Pylori, Syphilis – For the One-Step Detection of Syphilis, Chlamydia Trachomatis IgG ELISA Kit - (96 Tests), Chlamydia One-Step Extraction Test, Dengue One Step IgG/IgM and NS1 Combo Test - 2 in 1 Cassette, Dengue Virus NS-1 Antigen One-Step Rapid Test, Chagas IgG/IgM Diseases One-Step Rapid Test, One-Step HAV IgG/IgM Serum/Plasma Test, and TORCH 5 in 1 One-Step Kit Serum/Plasma Test (Toxo/CMV/Rubella/HSV 1/HSV 2) 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 any approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or any approved applications for investigational device exemptions under section 520(g) of the Act, 21 U.S.C. § 360j(g). In the case of the Ebola devices, your firm does not have an approved PMA, or an Emergency Use Authorization in effect pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices 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.
 
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, and should be addressed to:
 
CAPT Daniel Cline
Acting Director, Compliance Branch
Food and Drug Administration
19701 Fairchild
Irvine, CA   92612-2506
 
If you have any questions about the content of this letter please contact: Dr. William Vitale, Compliance Officer at 949-608-2919.
 
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, Director
Los Angeles District
 
 
Cc:
David M. Mazzera, Ph.D.
Chief, Food and Drug Branch
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
Sacramento, CA   95899-7413

Page Last Updated: 10/09/2015
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