Inspections, Compliance, Enforcement, and Criminal Investigations
North Coast Medical Inc. 07-Sep-07
Department of Health and Human Services
Public Health Service
San Francisco District
Via Federal Express
September 7, 2007
Mark E. Biehl, President & Chief Executive Officer
North Coast Medical Inc.
15305 Sutter Boulevard
Morgan Hill, CA 95037
Dear Mr. Biehl:
During an inspection of your establishment located in Morgan Hill, California, on April 6 through April 24, 2007, an investigator from the Food and Drug Administration (FDA) determined that your firm manufactures buffered iontophoresis electrodes. 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.
The inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 35l(h)), in that the methods used in, or the facilities or, controls used for their manufacturing, packing, storage, or installation are not in, conformance with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 824. We received a response from Assistant Operations Manager Kayihan dated 4/25/2007 concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations, that was issued to you. Mr. Kayihan's response promises to correct the observations within six (6) months but fails to provide any details or specifics regarding the corrective actions. As such, we cannot verify the adequacy of your proposed corrective actions.
The violations observed at the inspection of your firm include, but are not limited to, the following:
1. Failure to assure that management with executive responsibility reviews the suitability and effectiveness 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 and the manufacturer's established quality policy and objectives as required by 21 C.F.R. § 820.20(e). Specifically, executive management did not conduct any management review meetings in 2005 and 2006.
2. Failure to establish and maintain a design history file to demonstrate that the design was developed in accordance with the approved design plan and the requirements the Quality System Regulation as required by 21 C.F.R. § 820.3O(j). Specifically, your design documentation fails to, include design and development plans, design reviews, complete design verification and validation testing and results, and complete product specifications.
3. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements required by 21 C.F.R. § 824.50. Specifically, you utilize a [redacted] to design and manufacture your buffered iontophoresis electrodes and you have failed to establish or maintain any requirements, including quality requirements, that the [redacted] must meet. In addition, there is no procedure describing the qualification process for suppliers, or any documentation to show how you evaluate suppliers to determine their ability to meet any specified requirements, including quality requirements.
4. 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 C.F.R. § 820.22. Specifically, your procedures fail to require comprehensive audits of the following quality subsystems: Management Responsibility, Corrective and Preventive Action, Design Controls, and Purchasing Controls. In addition, quality audits were not performed between the audit of 2004 and the audit of 2007.
5. Failure to adequately establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 C.F.R.§ 820.100. Specifically, your CAPA procedure does not describe how you will investigate any quality problems other than those identified in complaints. The procedure also does not explain how the firm will implement corrective or preventive actions or verify the effectiveness of those actions. In addition, you have failed to document corrective and preventive actions that you have taken.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations 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 submissions for Class III devices to which Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected for Certificates to Foreign Governments will not be granted until the violations the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days of receipt of this letter of the 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.
Your response should be sent to: Russell A. Campbell, Compliance Officer, San Francisco District, 1431 Harbor Bay Parkway, Alameda, CA 94532. If you have any questions about the content of this letter, please contact Mr. Campbell at (510) 337-6861.
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 bring your products into compliance.
Barbara J. Cassens
U. S. Food and Administration
San Francisco District