Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District Office
1431 Harbor Bay Parkway
Alameda, CA 94502
Telephone: (510) 337-6886
FAX: (510) 337-6703
July 31, 2013
VIA UNITED PARCEL SERVICE
Chang F. Yu
LumiQuick Diagnostics, Inc.
2946 Scott Blvd.
Santa Clara, CA 95054-3312
Dear Mr. Yu:
During an inspection of your firm located in Santa Clara, CA on November 26 through December 7, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures QuickView Test Cards for the detection of cancer markers, such as Prostate-Specific Antigen (PSA), infectious pathogens, such as Treponema pallidum (the causative agent of syphilis) and Rotavirus, and cardiac markers, such as Troponin I. 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.
Our inspection revealed that the QuickView™ PSA, Syphilis Antibody, Rotavirus Antigen, and Troponin I Test Cards 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 approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for investigational device exemptions under section 520(g) of the Act, 21 U.S.C. § 360j(g). These devices are 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 devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
Devices classified under 21 CFR 866.3405 are exempt from premarket notification, unless they exceed the limitations on exemption at 21 CFR 866.9. Generic devices of this type include rotavirus assays, which fall under the “Enzyme Linked Immunosorbent Assay, Rotavirus” (LIQ) product code. The QuickView™ Rotavirus Antigen Test Card exceeds the limitation in 21 CFR 866.9(c)(6) because it is an in vitro device intended for identifying or inferring the identity of a microorganism directly from clinical material. The package insert for this device states that it is intended “for the rapid detection of rotavirus antigens in human stool specimen.” The device exceeds the limitation described in 21 CFR 866.9(c)(6) and thus falls outside the exemption from premarket notification. As a result, until FDA clears a 510(k) for this device, it is an unapproved class III device under section 513(f)(1) of the Act, 21 U.S.C. § 360c(f)(1).
For a device requiring a PMA, 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 devices 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 products may be legally marketed.
Our inspection also revealed that these devices 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 devices 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 establish medical device reporting (MDR) procedures as required by 21 CFR 803.17.
During the inspection, we learned that your firm does not maintain any written MDR procedures in violation of 21 CFR 803.17. We received a response from you on behalf of the firm, dated December 17, 2012, proposing to establish a MDR procedure to correct this violation. We subsequently received an update from Jeff C. Wang, Quality System Manager, dated February 8, 2013, attaching SOP-814, “Medical Device Reporting to US FDA.” We reviewed your firm’s responses and conclude they are not adequate.
The SOP’s stated purpose is to set forth the procedure for reports of product removals and corrections in compliance with FDA regulations (21 CFR Part 806). The SOP focuses almost exclusively on the firm’s internal process for determining when it will conduct a recall. The SOP does not address the internal systems that provide for (1) timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, (2) a standardized review procedure for determining when an event meets the criteria for reporting under 21 CFR Part 803 or (3) timely transmission of complete medical device reports to FDA (21 CFR 803.17(a)). Moreover, the SOP lacks any discussion of the documentation and record-keeping requirements set forth in 21 CFR 803.17(b). The firm’s belief, as stated in the SOP, that “[i]t is very unlikely that any malfunction/defect of Lumiquick product would result in a MDR reportable event,” does not relieve it of any of these requirements.
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 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. 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 the violations included in this Warning Letter.
This inspection also revealed that the methods used in, or the facilities or controls used for, manufacture, packing, storage, or installation of the devices are not in conformity with the current good manufacturing practice requirements of the Quality System regulations found at 21 CFR Part 820. The specific deficiencies were noted on a Form FDA-483, Inspectional Observations issued to you at the conclusion of the inspection. We have received your response dated December 17, 2012, and monthly updates from February to May. We will evaluate their adequacy and effectiveness during a follow-up inspection.
Your firm’s response should be sent to: Lawton W. Lum, Director of Compliance, 1431 Harbor Bay Parkway, Alameda, CA 94502. Refer to the Unique Identification Number 392748 when replying. If you have any questions about the contents of this letter, please contact: Sergio Chavez, Compliance Officer at (510) 337-6886 or (510) 337-6703 fax.
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.
Kathleen M. Lewis, J.D.