Inspections, Compliance, Enforcement, and Criminal Investigations
BioMedix Vascular Solutions, Inc. 16-Oct-08
Department of Health and Human Services
Public Health Service
Minneapolis District Office
October 16, 2008
RETURN RECEIPT REQUESTED
Refer to MIN 09-01
John A. Romans
President and CEO
BioMedix Vascular Solutions, Inc.
4215 White Bear Parkway
Saint Paul, Minnesota 55110-7646
Dear Mr. Romans:
During an inspection of your firm located in St. Paul, Minnesota, on June 17 through August 6, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the PADnet+ noninvasive cardiovascular blood flow monitoring system. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. This inspection revealed that this device is 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, its 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 (CFR), Part 820.
The quality system deviations include:
1. Failure of management with executive responsibility to ensure that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization, which is required by 21 CFR 820.20. Specifically, the system for complaint handling is not adequate (see #2 below); periodic management reviews have not ensured that the quality system satisfies the requirements of the Quality System Regulation; procedures for implementing Corrective and Preventive Action (CAPA) have not been implemented (see #3 below); and internal quality audits have not been conducted as frequently as required.(see #4 below).
2. Failure to investigate complaints involving the possible failure of a device to meet any of its specifications as required by 21 CFR 820.198(c). For example, no investigation. was conducted for the following PADnet+ systems that were returned after apparent device failures:
• Complaints #345, 378, 389, 397 and 432 - inaccurate measurements
• Complaints #337 and 366 - incorrect data storage
• Complaint #354 - irregular pressure recording
• Complaints #323 and 424 - cuffs not inflating
• Complaints #330 and 350 - not functioning
3. Failure to implement procedures for corrective and preventive actions as required by 21 CPR 820.100(a). Specifically, in the Corrective Preventive Action Reports (CPARs) noted below, the following requirements of Corrective and Preventive Action Procedure (SP14, Rev :D) were not completed:
• completing CPAR by due date;
• reviewing the CPARS and presenting a summary to Executive Management at Management Review
• investigating to determine "root" cause of the issue;
• identifying appropriate Corrective /Preventive action to address "root" cause;
• completing responsible person portion of CPAR form;
• forwarding forms to Management Representative for approval, and verifying effectiveness of action.
The following CPARs failed to meet the above requirements: CPAR #86 dated 7/7/06, CPAR #87 dated 9/26/2006, CPAR #88, dated 7/30/2007, CPAR #89 dated 7/30/2007; CPAR #90 dated 7/30/2007, CPAR #91 dated 7/30/2007, CPAR #93 dated 8/31/2007; CPAR #95 dated 8/30/2007, CPAR #96 dated 8/30/2007, CPAR #97 dated 8/30/2007, CPAR #98 dated 8/30/2007, CPAR #99 dated 9/7/2007, CPAR #100 dated 9/7/2007, CPAR #102 dated 10/06/2007, CPAR #104 dated 10/06/2007, CPAR #105 dated 10/06/2007, CPAR #106 dated 10/26/2007, CPAR #107 dated 12/07/2007, and CPAR #108 dated 12/07/2007.
4. Failure to conduct quality audits at sufficient regular intervals, as prescribed by internal procedures, to verify that the quality system is effective in fulfilling your quality system objectives. This is required by 21 CPR 820.22. Specifically, the Internal Quality Audit Procedure (SP17, Rev: C) requires that audits be conducted at a minimum of once per two calendar years for each specified process. The most recent audit was done on October 5, 2007, but the previous internal audit was conducted on December 14, 2004, which failed to meet the two year audit frequency requirement.
Additionally, during our post-inspection review of promotional brochures (ML-032 Rev. 1-08 and ML-024 Rev. 5-08) for your PADnet+ systems, we observed that the brochures contain the statement "FDA approved." However, your device has not received approval from the FDA. The PADnet+ device is marketed under a premarket notification [510(k)]. Under 21 CFR § 807.97 ("Misbranding by reference to premarket notification"), "[a]ny representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding."
We received a response from Will Rogers, Chief Technology Officer, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. The response discusses some corrective actions, but fails to provide complete evidence that corrections have been made: and will be effective going forward. In this case, a follow-up inspection will be necessary to determine the adequacy of your corrections.
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.
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. 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 Timothy G. Philips, Compliance Officer, at the address on this letterhead. If you have any questions about the content of this letter please contact Mr. Philips at (612)758-7133.
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.
W. Charles Becoat