| 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 |
Department of Health and Human ServicesWARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
April 18, 2011
WL 33-11
Mr. Edward Chen
Chief Executive Officer
Bionetek Corporation
3445 Fletcher Avenue
El Monte, California 91731
DearMr. Chen:
During an inspection of your firm located in El Monte, California,on January 5, 2011 through January 27, 2011, an investigator (or investigators) from the United States Food and Drug Administration (FDA) determined that your firm manufactures the CARDx Early Cardiac Diagnostic (ECD) system for investigational purposes. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is 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 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 controls used for its pre-production design are not in conformity with the current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received a response from you dated February 10, 2011, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. 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 to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). For example:
a. Your firm has not implemented procedures for design input, design output, design review, design verification, design validation, design transfer, or design changes
b. There is no documented evidence that your firm has performed design verification to ensure the CARDx ECD device design meets specified requirements.
We have reviewed your response and conclude that it is not adequate. Your firm provided Document SOP 1050 Rev 1, Design Control, to fulfill the requirements of 21 CFR 820.30. However, no specific implementation plan or timeline has been provided. Your firm has not provided any evidence that corrections and corrective actions have been implemented.
2. Failure to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation, as required by 21 CFR 820.30(b). For example, your firm has not established and maintained a design and development plan for the CARDx ECD device.
We have reviewed your response and conclude that it is not adequate. Your firm provided Document SOP 1050 Rev 1, Design Control, to fulfill the requirements of 21 CFR 820.30. However, no specific implementation plan or timeline has been provided. Your firm has not provided any evidence that corrections and corrective actions have been implemented.
3. Failure to establish and maintain a Design History File (DHF), as required by 21 CFR 820.30(j). For example, your firm has not established and maintained a design history file for the CARDx ECD device that demonstrates that the design was developed in accordance with the approved design plan.
We have reviewed your response and conclude that it is not adequate. Your firm provided Document SOP 1050 Rev 1, Design Control, to fulfill the requirements of 21 CFR 820.30. However, no specific implementation plan or timeline has been provided. Your firm has not provided any evidence that corrections and corrective actions have been implemented
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all 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 (15) business days from the date you receive this letter of the specific steps you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violation(s), or similar violation(s), from occurring again. Include documentation of the corrections and/or corrective actions you have taken. If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this warning letter.
Your response should be sent to:
Mr. Blake Bevill
Director, Compliance Branch
U.S. Food & Drug Administration
19701 Fairchild
Irvine, CA 92618
If you have any questions about the content of this letter please contact: Ms. Mariza M. Jafary, Compliance Officer, at (949) 608-2977.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. You should investigate and determine the causes of the violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Sincerely,
/S/
Alonza Cruse
District Director
Los Angeles District
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