| Public Health Service Food and Drug Administration |
Minneapolis District Office |
Department of Health and Human ServicesSeptember 1, 2010
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 10 – 19
Mark D. Rolison
President
President
Frontier Medical Products
140 South Park Street
Port Washington, Wisconsin 53074
140 South Park Street
Port Washington, Wisconsin 53074
Dear Mr. Rolison:
During an inspection of your firm located in Port Washington, Wisconsin, between June 7-July 9, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures blood pressure cuffs. 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 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (21 CFR), Part 820. We received your response dated July 14, 2010, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We address this response below. These violations include, but are not limited to, the following:
- Failure to establish procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example: You implemented on or around April 2010 a change in the (b)(4) and process used to manufacture blood pressure cuffs. You reference a “Procedure for Design Change” (SOP 1244-000) in your Quality Manual (QM1211-000, Rev. 01), however, this procedure does not exist. In addition, there is no evidence of: verification or validation activities being performed on the product change; review of the change in (b)(4); or approval of the change in (b)(4) before implementation of this change in production.
- Failure to establish and maintain adequate procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). For example: You have not implemented the Corrective and Preventive Action procedure entitled “Procedure for Risk Management” (PP1227-000, Rev. A), which requires the use of a CAPA form (F037) in that this form (F037) does not exist. In addition, issues not remedied through other systems (i.e. Nonconforming Material Activity and Audit Activity: Internal and External) were not logged into your CAPA system as required by “Procedure for Risk Management.”
- Failure to establish and maintain a complaint procedure that ensures complaints are received, reviewed and evaluated by a formally designated unit, as required by 21 CFR 820.198(a). For example: The customer complaint received 3/24/10 was not entered as a complaint as required by “Procedure for Complaint Processing” (PP1218-000, Rev. A). In addition, the form described in your procedure (F003) does not exist.
- Failure to establish and maintain procedures to ensure all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example: You have not implemented the “Procedure for Purchasing Process” (PP1222-000, Rev. 01) and the Supplier Questionnaire Form. The supplier of the (b)(4) used to manufacture blood pressure cuffs has not been evaluated for their ability to meet specifications. In addition, you have no approved supplier list required by “Procedure for Purchasing Process.”
- Failure to conduct quality 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. For example: “Procedure for Quality System Audits” (PP1216-000, Rev. A), section 6.1.1, requires all areas of the Quality System to be audited, at a minimum, annually, however, no quality audits have been conducted since 2006.
- Failure to ensure that management with executive responsibility review the suitability and effectiveness of the quality system at defined intervals, as required by 21 CF 820.20(c). For example: Quality Manual (QM1211-000, Rev. 01), section 5.6.1 requires management reviews to be conducted at least four times annually, however, no management reviews have been conducted since 2006.
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 FDA 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.
We received your response dated July 14, 2010, concerning the observations noted on the Form FDA 483. The response promises correction, however, the response is inadequate in that you have not provided any documentation to demonstrate how the violations will be corrected.
Additionally, for your information, under section 510 of the Act (21 U.S.C § 360), firms who are involved in the manufacture, preparation, propagation, compounding, or processing of medical devices are required to annually register with the FDA. In September 2007 section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means (section 510(P) of the Act [21 U.S.C. 360(p)] during the period beginning October 1st and ending on December 31st of each year. During our inspection, it was determined that you have not fulfilled your annual registration and listing requirements since 2007. Your firm, by definition a manufacturer, is required to register and list the devices and the activities performed on those devices annually with the FDA. Information about device establishment registration and listing requirements can be found on our website at: http://wwwfda.gov/deviceregistrationandlisting.
Please notify this office in writing within 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. If your planned correction 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 delay and the time within which the corrections will be completed.
Your response should be directed to Melissa I. Michurski, Compliance Officer, at the address listed above. You can contact Ms. Michurski at (612)758-7185 with any questions regarding this letter.
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, issued at the conclusion 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.
Sincerely,
/S/
Gerald J. Berg
Gerald J. Berg
Director
Minneapolis District
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