West Coast Medical Imaging 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: 28 - 02

Inspection ID: 2045370009

CFN: 20-30,680

FEI: 3000204024

Stewart Lapin, M.D.

Medical Director

West Coast Medical Imaging

Larchmont Radiology

2010 Wilshire Blvd.; Suite #408

Los Angeles, CA 90057-3598

Dear Dr. Lapin:

We are writing to you because on December 26, 2001, 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: Phantom quality control (QC) records were missing for the weeks from April 11^th through May 16^th of the year 2001 for unit #7 (a [redacted] machine, model [redacted], serial number [redacted]) which is located on Mobile #7. [Title 21 Code of Federal Regulations 900.12(e)(2)]

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 qualify of mammography at your facility, it represents a serious violation

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 Directed

Plan of Correction (DPC), charging your facility for the 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 findings that were listed on the

inspection report provided to you at the close of the inspection. These Level 2 findings

are:

- Level 2: A performance verification test was not conducted after each move for mobile

unit #7 (a [redacted] machine, model [redacted], serial number [redacted])

which is located on mobile #7. [Title 21 Code of Federal Regulations 900.12(e)(7)]

- Level 2: A performance verification test was not conducted after each move for mobile

unit #8 (a [redacted] machine, model [redacted], serial number [redacted] which is located on mobile #8. [ Title 21 Code of Federal Regulations 900.12(e)(7)]

- Level 2: The tune period between the previous and current surveys for x-ray unit #11 (a

[redacted] machine, model [redacted], serial number [redacted]) exceeded fourteen (14) months (Date of previous survey: March 27, 2000 and Date of current Survey: December 04, 2001). , [Title 2 1 Code of Federal Regulations 900.12(e)(9)]

It is necessary for you to act on this matter immediately. Please explain to this offic4z, 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

I9900 MacArthur Blvd. ; Suite #300

Irvine, CA 92612-2445

Phone: (949) 7987600

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 contact Scott Gag (the Compliance Officer

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

Sincerely,

Alonza E. Cruse

District Director