|Subject:||CGMP/QSR/Medical Device Reporting/Misbranded|
|Issuer:||Los Angeles District Office|
|Issued:||July 19, 2010||Closed:||May 11, 2012|
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
RETURN RECEIPT REQUESTED
July 19, 2010
12099 W. Washington Blvd., Suite 304
Los Angeles, CA 90066
Dear Mr. Bicher:
During an inspection of your firm located in Los Angeles, California on January 19, 2010 through January 21, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures BioSensor-T (micro-thermocouples), for use in hypothermia treatment systems, which is a finished device. 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 your 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 device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 C.F.R. Part 803 Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. For example, your firm has no MDR procedures.
You 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 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 deviations 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) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations; or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
In addition, FDA has noted non-conformances with regard to section 501(h) of the Act [21 U.S.C. § 351(h)], due to deficiencies of the current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found in 21 CFR 820. These non-conformances include, but are not limited to the following:
1. 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). Specifically, your firm has no complaint procedures.
Your response should be sent to:
Director, Compliance Branch
U.S. Food and Drug Administration
Irvine, CA 92612-2506
If you have any questions about the content of this letter please contact Ms. Mariza 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 violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations 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 assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Alonza E. Cruse
Los Angeles District