Torrance Memorial Breast Diagnostic Center II 15-Feb-02

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

19900 MacArthur Blvd., Ste 300

Irvine, California 92612-2445

Telephone (949) 798-7600

WARNING LETTER

Certified Mail

Return Receipt Requested

February 15, 2002

W/L Number: 29 - 02

Inspection ID: 2151860005

CFN: 20-32,194

FEI: 3003146706

Patricia Sacks, M.D.

Radiology Director

Torrance Memorial Breast Diagnostic Center II

824 East Carson Street; Suite #208

Carson, CA 907452262

Dear Dr. Sacks:

We are writing to you because on February 11, 2002, your facility was inspected by a

representative of the State of California acting in behalf of the U. S. Food and Drug

Administration (FDA). This inspection revealed a serious regulatory problem involving

the mammography at your facility.

Under a United States Federal law, the Mammography Quality Standards Act of 1992

(MQSA), 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 inspection revealed the following Level 1 finding at your

facility:

- Level 1: Mammograms were processed in processor #l (a [redacted] machine), which is

located in the daylight room, when it was out of limits on at least five (5) days. Specifically, while the new aim values were being established after a processor chemistry

change, the processor was out of limits. For some period of time, you were using two (2)

"channel" data charts showing that on one chart the data was out of limits while the

second chart was in limits. [Title 21 Code of Federal Regulations 900.12(e)(l)]

The specific problem noted above appeared on your MQSA Facility Inspection Report

which was issued to your facility at the close of the inspection. This problem is identified

as Level 1 because it identifies a failure to meet a significant MQSA requirement.

Because this condition may be symptomatic of serious underlying problems that could

compromise the quality of mammography at your facility, it represents a serious violation cost .of on-site monitoring, assessing civil money penalties up to $10,000 for each failure to substantially comply with, or each day of failure to substantially comply with, MQSA Standards, suspension or revocation of your facility?s FDA certificate, or obtaining a court injunction against further mammography.

In addition, your response should address the Level 2 finding that was listed on the

inspection report provided to you at the close of the inspection. The Level 2 finding is:

- Level 2: The mammography processor equipment evaluation (by a medical physicist)

for processor #l (a [redacted] machine) was not performed. Specifically, on January 28,

2001 your facility changed processor chemistry. After establishing new aim values, you

failed to contact a MQSA-qualified medical physicist to re-evaluate all processor and

phantom QC. [21 Code of Federal Regulations 900.12(e)(9)]

It is necessary for you to act on this matter immediately. Please explain to this office, in

writing, within fifteen (15) working days from the date you received this letter:

- the specific steps you have taken to correct all of the violations noted in this letter;

- each step your facility is taking to prevent the recurrence of similar violations;

- equipment settings (including technique factors), raw test data, and calculated final

results, where appropriate; and

- please provide sample records that demonstrate proper record keeping procedures, if the

findings relate to quality control or other records (Note: Patient names or identification

should be deleted from any copies submitted).

Please submit your response to:

Thomas L. Sawyer

Director, Compliance Branch

U.S. Food & Drug Administration

19900 MacArthur Blvd.; Suite #300

Irvine, CA 92612-2445

Phone: (949) 798-7600

Finally, you should understand that there are many FDA requirements pertaining to

mammography. This letter pertains only to findings of your inspection 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 (telephone number: l-800-838-7715) or through

the Internet at http://www.fda.gov.

If you have more specific questions about mammography facility requirements, or about

the content of this letter, please feel free to Scott Goff (the Compliance Officer assigned

to this case) at telephone number 949-798-7644.

Sincerely,

Alonza E. Cruse

District Director