Inspections, Compliance, Enforcement, and Criminal Investigations
Pro Trainers Choice Company, Inc. 03-Jul-06
Department of Health and Human Services
Public Health Service
July 3, 2006
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 06-35
Richard Diana, President
Pro Trainers Choice Company, Inc.
P.O. Box 3953
5803 NW Newberry Hill Road
Silverdale, WA 98383-3953
Dear Mr. Diana:
On May 3 and 24, 2006, Food and Drug Administration (FDA) investigators conducted an inspection of your establishment located at 5803 NW Newberry Hill Road, Silverdale, Washington. FDA has determined that your establishment markets the Precision Ice Treatment System, which is a medical device under section 201(h) [21 U.S.C. 321(h)] of the Federal Food, Drug, and Cosmetic Act (the Act).
Our inspection documented significant violations of the Quality System (QS) Regulation, Title 21, Code of Federal Regulations (CFR), Part 820. These violations cause the device you manufacture to be adulterated within the meaning of Section 501(h) of the Act [21 U.S.C. 351(h)]. Your devices are also misbranded within the meaning of Section 502(t)(2) of the Act [21 U.S.C. 352(t)(2)] because your firm failed to establish and maintain written medical device reporting (MDR) procedures, as required by Section 519 of the Act [21 U.S.C. 360i] and the MDR Regulation, 21 CFR Part 803.
The deficiencies are as follows:
Quality System Regulation
1. Your firm's management with executive responsibility failed to establish its policy and objectives for, and commitment to quality. Management shall ensure that the quality policy is understood, implemented, and maintained at all levels of your organization as required by 21 CFR 820.20. Specifically, you have failed to establish quality system procedures and instructions per 21 CFR 820.20(e), and you have failed to establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured per 21 CFR 820.20(d). You have manufactured approximately [redacted] units of your Precision Ice Treatment System and you have no quality system procedures or a quality plan in place at your firm.
2. Your firm failed to establish procedures for quality audits and conduct such audits and 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. You have been producing this device for several years, and you have never conducted a quality audit.
3. Your firm failed to establish and maintain procedures for implementing corrective and preventive action (CAPA) as required by 21 CFR 820.100(a). Your firm has never initiated corrective or preventive actions and you have not established CAPA procedures.
4. Your firm failed to establish procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR 820.198(a). You have not established procedures for handling complaints even though you have manufactured approximately [redacted] units of the Precision Ice Treatment System.
5. You have failed to establish and maintain procedures to control all documents that are required by 21 CFR 820.40. Furthermore, you have not designated an individual to review for adequacy and approve prior to issuance all documents established to meet the requirements per 21 CFR 820.40(a). Specifically, you have no device master record. On May 25, 2006, you were able to provide to our investigators with several documents, but you could not provide assurance that these documents are being followed during production and without modifications.
6. You have failed to establish and maintain procedures for acceptance activities such as inspections, tests, or other verification activities, as required by 21 CFR 820.80(a). You have not established acceptance activities for the Precision Ice Treatment System that you have manufactured and distributed, and for those you had stored at your facility at the time of the inspection.
7. You have failed to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, as required by 21 CFR 820.50. During the inspection, your employee provided our investigator with a document titled "Receiving and Shipping Procedures." This document does not meet the regulation as it does not provide for written specifications for each component you receive from suppliers.
8. You have failed to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b).
9. You have failed to establish and maintain procedures to control the design of the device in order to ensure that specific design requirements are met, as required by 21 CFR 820.30(a). You have not established procedures for controlling the design of the Precision Ice Treatment System. Also, you have failed to establish and maintain plans that describe or reference the design development activities and define responsibility for implementation, as required by 21 CFR 820.30(b). You did not establish a design and development plan for the Precision Ice Treatment System, including defining responsibility, describing the interfaces with different groups or activities that provide or result in input to the design. You had no reviews, updates, or approvals of the design of the Precision Ice Treatment System, as it was being developed, produced, marketed, and distributed the device.
Medical Device Reporting (MDR)
10. You have failed to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.
This letter is not intended to be an all-inclusive list of 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.
We acknowledge the receipt of your response, dated June 13, 2006, to the Form FDA-483, Inspectional Observations, issued to your attention on May 24, 2006. We have reviewed your written response and take note of your acknowledgement of the deficiencies related to your quality system and your promise to implement corrections by October 31, 2006. However, we could not determine whether your response was adequate or that you understand the concept of the regulations because you did not provide any supportive documentation or written procedures for our review. 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. Also, no requests for Certificates to Foreign Governments 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties. Please notify this office within 15 working days of receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to identify and make corrections to any underlying system problems necessary to ensure that similar violations will not recur. Please include any and all documentation to show that adequate correction has been achieved. In the case of future corrections, an estimated date of completion, and documentation showing plans for correction should be included with your response to this letter.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 2220123rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Lisa M. Elrand at (425) 483-4913.
Charles M. Breen