Inspections, Compliance, Enforcement, and Criminal Investigations
Dux Industries Inc. 01-Jun-06
Department of Health and Human Services
Public Health Service
Los Angeles District
CERTIFIED MAIL .
RETURN RECEIPT REQUESTED
June 1, 2006
Paul D. Porteous
Dux Industries, Inc.
600 E. Hueneme Road
Oxnard, CA 93033
Dear Mr . Porteous:
During an inspection of your medical device firm located in Oxnard, California, conducted from March 21 to April 10, 2006, our investigators determined that your firm manufactures dental alginate impression materials and temporary dental cement. These products are devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
Our inspection disclosed that these devices are adulterated within the meaning of Section 501(h) of the Act, in that the methods used in, or the facilities or controls used for manufacturing, packing, and storage are not in conformance with the Good Manufacturing Practice (GMP) requirements for the Quality System Regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820, as follows:
1. Failure of the management with executive responsibility to establish a quality policy and objectives for, and commitment to, quality for specific devices manufactured that is understood, implemented and maintained at all levels of the organization as required by 21 CFR 820.20(a). Specifically, your firm has no written documentation describing' the overall intentions and direction of your organization with respect to quality, as established by management with executive responsibility.
2. Failure to establish, maintain and control a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured and how the requirements for quality will be met for the specific devices manufactured as required by 21 CFR 820.20(d). Specifically, your firm has no written documentation that defines the quality practices, resources, and activities relevant to devices that are designed and manufactured.
3. Failure to establish procedures to ensure that management with executive responsibility reviews the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency and document that the quality system requirements are met as required by 21 CFR 820.20(c). Specifically, your firm does not maintain written management review procedures or document management reviews.
4. Failure to establish and implement and control procedures for conducting quality audits, and to conduct such audits, to verify that the quality system is effective in fulfilling the quality system objectives [21 CFR 820.22]. Specifically, your firm has not established any internal audit plans for calendar years 2005 or 2006.
5. Failure to establish and maintain procedures for implementing corrective and preventive action as required by 21 CFR 820.100. Specifically, your firm has no documentation describing the evaluation of potential causes of nonconforming product or other quality problems once they have been identified.
6. Failure to establish and implement control procedures for receiving, reviewing, and evaluating complaints by a formally designated unit to ensure that all complaints are processed in a uniform and timely manner as required by 21 CFR 820.198. Specifically your firm has no established procedures to determine whether complaints should be reported pursuant to 21 CFR Part 803, in violation of 21 CFR 820.198(a)(3).
During the above specified inspection period, our investigators also inspected your quality system activities as they pertain to your other merged corporate entities, namely [redacted] which appear to be marketed under the Dux Industries brand name. Our investigators also observed that these business entities also manufacture sterilization and disinfection patient care items, namely sterilizing pouches and tissue management materials, namely drug impregnated dental braids, knits and cords. The drug impregnated dental braid, knits, and cords are deemed a combination product as defined by 21 CFR 3.2(e)(1)
We acknowledge receipt of your letter dated April 24, 2006, which was prepared in response to the Form FDA 483 issued to your firm at the conclusion of our inspection on April 10, 2006. In your response, you acknowledge that your firm manufactures drug-device combination products, but assert that under the final rule, Definition of Primary Mode of Action of Combination Products, 70 Fed. Reg. 164, 49848 (2005), your combination products are medical devices and subject to regulation only under 21 CFR 820. Your firm has misinterpreted the final rule. While the rule sets forth definitions of mode of action and primary mode of action, and the criteria used by the Agency for assigning combination products to an Agency component for lead regulatory review, it does not address current good manufacturing practice regulation. Thus, for example, in response to questions concerning the current good manufacturing practice regulations, the Agency stated, at page 49855, that the final rule applies only to the jurisdictional assignment of combination products to an agency component for review and regulation. The Agency went on to state that the final rule does not address the specific regulatory authorities to be applied to a combination product.
With regard to current good manufacturing practice, you may wish to refer to the Draft Guidance for Industry and FDA on Current Good Manufacturing Practice for Combination Products, which may be found at www.fda.gov/oc/combination/. In that document, the Agency states that current good manufacturing practice regulations for both sets of constituent parts of a .combination product (e.g., drug and device)apply to the combination product. The document sets forth the Agency's current thinking on how these requirements may be met. The Agency notes that because of the general similarity between the cGMP and QS regulations, in a properly implemented quality system program, compliance with both sets of regulations can generally be achieved because under a more general requirement in one set of regulations, it will be possible to implement a practice that complies with a more specific requirement in the other set of regulations. At page six of the document, the Agency identifies key provisions of the cGMP and QS regulations that differ in their specificity, and that should be carefully considered by combination product manufacturers to ensure compliance with both the cGMP and QS regulations.
Additionally, with respect to the comment in your response letter about the "brevity" of your records and that the Agency does not value their conciseness, it is your responsibility to assure that you establish procedures to satisfy the applicable regulatory requirements and your established quality policy and objectives. While your company employees may be familiar with their obligations in the performance of their duties, your procedures included as attachments with the response do not provide sufficient detail and instructions to document compliance with applicable requirements. For these reasons, the District has determined that your written response is inadequate.
Because of these concerns and the failure of your company to undertake corrective actions and establish preventive actions to eliminate the recurrence of significant quality system problems found during our March 18 to 20, 2003, inspection, which were found uncorrected, we are requesting a regulatory meeting to be conducted at our office with your company to discuss these concerns. Please contact Senior Compliance Officer, Dannie E. Rowland at 949-608-4448 so meeting arrangements can be made to each party's satisfaction.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the Form FDA 483 issued at the conclusion of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance system. You are responsible for investigating and determining the causes of the violations identified by the FDA. If the causes are determined to be systems problems, you must promptly initiate permanent corrective actions.
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, no pre-market submissions for devices to which the GNP deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for Certificates For Exportability will be approved until the violations related to the subject devices have been corrected.
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 penalties.
Please notify this office in writing within 15 working days of receipt of this letter, of the specific steps you to correct the noted violations, including an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur. 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.
If you have any questions relating to this letter please contact Senior Compliance Officer, Dannie E. Rowland at 949-608-4448. You may obtain general information about all of FDA's requirements for manufacturers of medical devices through the Internet at http://www.fda.gov.
Please submit your response to:
Pamela B. Schweikert, Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2445
Alonza E. Cruse
Los Angeles District Office