Avacen Inc 10/23/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
October 23, 2013
WL # 01-14
Mr. Thomas G. Muehlbauer
President and CEO
650 Columbia Suite 311
San Diego, CA 92101
Dear Mr. Muehlbauer:
During an inspection of your firm located at 650 Columbia Suite 311, San Diego, California, from July 24, 2013, to July 25, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures The Avacen Thermal Exchange System’s (TATES). 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 function of the body.
This inspection revealed that these devices are 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. These violations include, but are not limited to, the following:
- Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). Specifically, your firm could not provide any corrective and preventative action procedures.
- Failure to establish and maintain adequate procedures to control the design of the device in order to ensure that specified requirements are met, as required by 21 CFR 820.30(a). Specifically, your firm could not provide any design control procedures.
- Failure to maintain complaint files and establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically, prior to 7/24/2013 your firm did not have any complaint handling procedures. At the conclusion of the inspection your firm provided the FDA investigator with a Complaint Processing Procedure dated 7/24/2013, however this procedure is inadequate. For example, your procedure does not describe when an investigation is required, the process for evaluation or investigation, the process for MDR evaluation and reporting and does not include a timeline for these processes.
- Failure to establish and maintain procedures for acceptance activities, including inspections, tests, or other verification activities, as required by 21 CFR 820.80(a). Specifically, your firm could not provide any acceptance activities procedures.
- Failure to establish and maintain adequate procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. Specifically, your firm could not provide any purchasing control procedures.
- Failure to establish and maintain procedures to ensure that Device History Records (DHR’s) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record (DMR), as required by 21 CFR 820.184. Specifically, your firm could not provide a device history record procedure.
- Failure to establish and maintain adequate procedures for management review as required by 21 CFR 820.20(c). Specifically, your firm could not provide a management review procedure.
- Failure to establish and maintain procedures to control all documents, as required by 21 CFR 820.40. Specifically, your firm could not provide any document control procedures.
- Failure to establish and maintain 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.
We received your response dated August 8, 2013; however the adequacy of your response cannot be determined at this time since the corrections were in progress and supporting documentation was not provided for our review.
Our inspection also revealed that The Avacen Thermal Exchange System (TATES) is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do 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 (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). 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 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) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency, 21 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm
. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
The Food and Drug Administration Center for Devices and Radiological Health (CDRH) sent your firm a letter dated March 23, 2011, acknowledging receipt of your 510(k) submission for TATES and a second letter dated May 13, 2011, requesting additional information pertaining to your 510(k) submission. Furthermore, a third letter dated November 10, 2011, was sent to your firm notifying you that in accordance with 21 CFR 807.87(1), your 510(k) submission was considered closed since more than 30 days had elapsed since additional information was requested. All three letters stated that your firm may not place this device into commercial distribution until your firm receives a letter from FDA allowing you to do so and the letter dated November 10, 2011, stated that if your firm markets the device without FDA clearance/approval, your firm will be in violation of the Federal Food, Drug, and Cosmetic Act.
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 (15) 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 all violations included in this Warning Letter.
Your firm’s response should be sent to:
Mr. Blake Bevill
Director, Compliance Branch
United States Food and Drug Administration
Irvine, CA 92612-2506
If you have questions regarding this letter, please contact Marco Esteves, Compliance Officer, at 949-608-4439.
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.
Alonza E. Cruse, Director
Los Angeles District
Hugo Cornejo, Acting Branch Chief
Food and Drug Branch
California Department of Public Health
1500 Capitol Ave. – MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413