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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Jones, Alison M 10-Jun-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Center for Biologics Evaluation and Research
1401 Rockville Pike
Rockville MD 20852-1448


JUN 10 2005

By Certified Mail - Return Receipt Requested
And by Facsimile Transmission

CBER--05--021

Warning Letter

Alison M. Jones
Tapestry Health Systems. Inc.
320 Riverside Drive
Florence, Massachusetts 01062

Dear Ms. Jones:

This letter describes the results of a Food and Drug Administration (FDA) inspection that was conducted from February 15 through February 18, 2005. FDA investigator M. Patricia Murphy met with you to review your conduct of a clinical study entitled [redacted]. FDA conducted this inspection under the agency's Bioresearch Monitoring Program that includes inspections designed to review the conduct of research involving investigational devices.

At the end of the inspection, a Form FDA 483, Inspectional Observations, was issued and discussed with you.

We have determined that you violated regulations governing the proper conduct of clinical studies involving investigational devices, as published in Title 21, Code of Federal Regulations (CFR), Parts 50 and 812 (available at http://www.access.gpo.gov/nara/cfr/index.html). The applicable provisions of the CFR are cited for each violation listed below.

1. You failed to protect the rights, safety, and welfare of the subjects under your care, and you failed to ensure that the investigation was conducted according to the investigational plan, the signed agreement, and applicable FDA regulations, including Part 50. [21 CFR § 812.100].

A.

Protocol sections 8.0 and 9.0 require that enrolled subjects be between 18 and 55 years of age. Subjects with life threatening illnesses [redacted] as well as those with suppressed immune systems, were to be excluded from the study. You failed to document that the 149 subjects you enrolled in 'the study met the enrollment criteria of health status and age. Review of a list prepared after completion of the study with the date of birth for 99 of the 149 enrolled subjects showed that you enrolled four subjects not meeting the age requirements. Subjects [redacted] were enrolled although these subjects were under the age of 18. Subject [redacted] was enrolled although this subject exceeded the age requirement of 55.

 

B.

You violated protocol sections 7.3, 7.4, and 10.0 which provide that the "participant will be advised of the results and provided the required counseling of both the rapid and confirmation tests." There is no documentation to show that this requirement was met in at least 75 cases.

 

C.

Protocol section 10.0 directs that "Samples will be shipped to the [redacted] daily." Review of the specimen shipping forms shows that you failed to ship at least 75 of 149 samples to the central laboratory on the day they were obtained. Delays in shipping ranged from two to seven days for specimens documenting the shipping date. Fifty specimens had no documented shipping date, but the time from collection date to date received at the central reference lab ranged," 'from three to eleven days.

 

2. You failed to obtain Informed consent In accordance with the provisions of 21 CFR Part 50. [21 CFR 812.100].

A.

You failed to obtain informed consent prior to the enrollment and testing of the following five subjects: [redacted] Although these subjects were enrolled and tested on December 11, 2003, none signed and dated an informed consent document until December 12, 2003.

 

B.

The informed consent form offers the following two choices intended to determine the subjects' consent and [redacted] "I do/do not (please circle one) consent to participate in the study as described and provide the required blood samples and be [redacted] and 2) "I have/have not (please circle one) received treatment for [redacted]". At least 50 of the 149 signed consent forms had no mark to indicate the subjects had made a selection.

 

C.

The informed consent document did not clearly indicate the purpose of the research as required by 21 CFR 50.25. According to the informed consent document, the purpose of this clinical trial was to test the performance of "two experimental [redacted]. However, Protocol section 2.0 describes the objective of this clinical study as establishing the performance of only one [redacted].

 

D.

The informed consent form, version 11/10/03, approved by the Institutional Review Board (IRB) on 12/9/04 required the name and signature of a doctor. Although you are not a doctor, you signed the consent document on the line designated for the doctor.

 

This violation was not included on the Form FDA 483.

3. You failed to maintain accurate and complete records of each subject's case history, including data on the condition of each subject upon entering, and during the course of, the investigation and you failed to maintain accurate, complete and current records relating to the receipt, use, and disposition of devices. [21 CFR 812.140(a)(2) and (3)].

A.

As described in item 1.A above, you failed to document that the 149 enrolled subjects met the health status and age enrollment criteria.

 

B.

Protocol section 15.0 requires that controls be run daily at a minimum. Protocol section 10.0 requires that copies of all data corresponding to all specimens will be forwarded to [redacted] via fax daily. The [redacted] Control Form faxed from your site to [redacted] did not include documentation of controls run on the following three days: 12/19/03, 12/22/03, and 1/2/04 for 10 subjects. Notations on 12/19/03 for Lot [redacted] controls, 12/22/03 for Lot [redacted] controls, and 1/2/04 for Lot [redacted] controls appear to have been inserted between the lines on the first page of your control records. Additionally, further the quality control records at your site found that the original Control Forms pages 2 and 3 were not available for testing conducted from 1/6/04 through 1/22/04. During the FDA inspection the investigator noted that the original documents were lost and [redacted] supplied copies of these two pages to you.

 

This letter is not intended to contain an all-inclusive list of deficiencies "in your clinical study of investigational devices. It is your responsibility as the clinical investigator to ensure adherence to each requirement of the law and applicable regulations and to protect the rights, safety, and welfare of subjects under your care.

You should notify this office, in writing, within fifteen (15) business days of receipt of this letter, of the steps you plan to implement to prevent the recurrence of similar violations in future studies. Your response should include any documentation necessary to show that correction has been achieved.

This Warning Letter is issued to you because of the serious nature of the observations noted at the time of the FDA inspection. Please be advised that failure to implement effective corrective actions and/or the commission of further violations may result in the initiation of enforcement action(s) without further notice. These actions could include injunction and initiation of clinical investigator disqualification proceedings, which may render you ineligible to receive investigational devices.

Please send your written response to:

Janet K. White
Division of Inspections and Surveillance (HFM-664)
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike, Suite 200N
Rockville, Maryland, 20852-1448
Telephone: (301) 827-6339

We request that you send a copy of your response to the FDA District Office listed below.

Sincerely

/s/

Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research