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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Mission Primary Care Clinic 24-Jul-03

Department of Health and Human Services' logo

Public Health Service
Food and Drug Administration

  New Orleans District Office
Nashville Branch Office
297 Plus Park Blvd.
Nashville, TN 37217
Telephone: 615-761-5360
Facsimile: 615-761-5391

July 24, 2003

Bill Fulcher, Administrator
Mission Primary Care Clinic
1901 Mission 66
Vicksburg, Mississippi 39180

Dear Mr. Fulcher:

Warning Letter No. 03-NSV-19

An inspection of your facility was conducted on July 11, 2003 by a representative of the State of Mississippi acting on behalfof the Food and Drug Administration (FDA). This inspection revealed a serious compromise in the quality of the mammography services offered by this facility.

Under the Mammography Quality Standards Act of 1992 (MQSA), 42 U.S.C. 236b, your facility must meet specific requirements for mammography. These requirements help protect the health of women by assuring that a facility can perform quality mammography.

The recent inspection at this facility revealed the following Level 1 findings:

Level 1

Mammograms were processed in processor 1, [redacted] or [redacted] Darkroom, at site Mission Primary Care Clinic, when it was out of limits on at least 5 days (Period 1)

- 21 CFR 900.12(e) (1) (i),(ii),(iii)

Processor QC records in the month of 01/2003 were missing for at least 30% (at least 5 consecutive days) of operating days for processor 1, [redacted] or [redacted] Darkroom at site Mission Primary Care Clinic (Period 2)

- 21 CFR 900.12(e)(2)(i),(ii),(iii)

These specific deficiencies noted above appeared on the MQSA Post Inspection Report which was sent to this facility by the state inspector along with instructions on how to respond to these findings. Because these conditions may be symptomatic of serious underlying problems that could compromise the quality of mammography at this facility, they represent violations of the law which may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, placing your facility under a Direct Plan of Correction, charging your facility for the cost of on-site monitoring, seeking civil money penalties up to $10,000 for each failure to substantially comply with MQSA standards, seeking suspension or revocation of your facility’s FDA certificate, or seeking a court injunction against further mammography. [See 42 U.S.C. 263b(h)-(j)]

In addition, you should address the following Level 2 deficiency that was also listed on the inspection report:

Level 2

Corrective actions for processor QC failures were not documented at least once for processor 1, [redacted] or [redacted], Darkroom, at site Mission Primary Care Clinic (Period 1)

- 21 CFR 900.12(e)(1)(i),(ii), (iii)

It is your responsibility to ensure adherence to each requirement of MQSA and FDA’s regulations. You are responsible for investigating and determinin g the cause of these deficiencies as identified and to promptly initiate permanent corrective actions.

Within 15 working days after receiving this letter, you should notify FDA in writing of each step your facility is taking to prevent the recurrence of any similar violations. Your response should include:

- The specific steps you have taken to correct the Level 1 and Level 2 violations as outlined in this letter;
- Each step your facility is taking to prevent the recurrence of similar violations;
- Sample records that demonstrate proper record-keeping procedures relating to quality control or any other records that are appropriate to the noncompliance finding (NOTE: Patient names or other information that would likely reveal the patient’s identity should be deleted from any copies submitted).

If your facility is unable to complete these corrective actions within 15 working days, you should state the reason for the delay and the time within which the corrections will be completed.

Your reply should be directed to Joseph E. Hayes, Compliance Officer, Food and Drug Administration, 297 Plus Park Boulevard, Nashville, Tennessee 37217, telephone 615/781-5389, extension 125, with a copy to the State of Mississippi. Should you have questions regarding the technical aspects of this letter or concerning MQSA standards, you may call Karen Smallwood, Radiation Specialist, at 615/781-5380,
extension 144.

Finally, you should understand that there are many requirements pertaining to mammography. This letter pertains only to violations related to the recent inspection of your facility and does not necessarily address other obligations you have under the law. You may obtain general information about all of FDA’s requirements for mammography facilities by contacting the Mammography Quality Assurance Program,
Food and Drug Administration, P.O. Box 6057, Columbia, MD 21045-6057 (1-800-838-7715) or through the Internet at http://www.fda.gov/cdrh/mammography/index.html


Carl E. Draper
Director, New Orleans District