Inspections, Compliance, Enforcement, and Criminal Investigations
Frontier Medical Products 9/1/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
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.
Gerald J. Berg