Office of Constantine M. Voyagis 11-Mar-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

March 11, 2002

W/L Number: 30 - 02

Inspection ID: 1289670007

CFN: 20-29,624

FEI: 1000518953

Constantine Voyagis, M.D.

Medical Director

Office of Constantine M Voyagis

436 North Roxbury Drive, Suite # 102

Beverly Hills, CA 90210-5056

Dear Dr. Voyagis:

We are writing to you because on January 30, 2002, your facility was inspected by a

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

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

the mammography at your facility.

Under the Mammography Quality Standards Act of 1992 (MQSA), 42 USC. ? 263b,

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 findings at your facility:

- Level 2: 1 of 5 random reports reviewed did not contain an acceptable assessment

category. This is a REPEAT violation.

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 repeat Level 2 because it identifies a failure to meet a significant MQSA requirement

in Title 21 Code of Federal Regulations section 900.12(c)(l)(iv).

The background on this situation involves a trend of MQSA noncompliance. On January

23,2001, your facility was inspected (Inspection ID number: 1289670006) with a partial

finding of "***S of 5 random reports reviewed did not contain an assessment

category***.". On March 29,200 1, you wrote us a letter and stated "***Also beginning

on this date assessment categories on the mammography reports will be implemented,

according to the ACR Breast Imaging Reporting and Date System* ** ." On April 17, 2001, we telephoned you and explained that the written response was not acceptable.

Further, it was explained what was required to bring your facility into compliance. We

received your letter dated April 30, 2001; however, this correspondence failed to even

mention the corrective action of bringing the assessment category problem to resolve. On

May 14, 2001,.we telephoned you again explaining that there was no response to the

Level 2 problem. No further correspondence was received from you in this matter. For

your 2002 MQSA inspection, the same problem has been detected again. As you should

be aware, the MQSk regulations are quite specific on what the? written report of the

results of each mammography examination shall contain including final assessment of

findings terminology.

- Level 2: Medical audit and outcome analysis was not performed annually. This is a

violation of Title 2 1 Code of Federal Regulations section 900.12(f)(2).

- Level 2: Medical audit and outcome analysis was not done separately for each

individual. This is a violation of Title 21 Code of Federal Regulations section

900.12(f)(l).

- Level 2: Medical audit and outcome analysis was not done for the facility as a whole.

This is a violation of Title 21 Code of Federal Regulations section 900.12(f)(l).

- Level 3: The required personnel qualification documents were not available during the

inspection. This is a REPEAT violation. This is a violation of Title 21 Code of Federal

Regulations section 900.12(a)(4).

Because these conditions may be symptomatic of serious underlying problems that could

compromise the quality of mammography at your facility, they represent serious

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

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.

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 receive 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).

Your response should also specifically address the repeat violations that were not

corrected from the previous inspection and why they were not corrected prior to the

inspection of January 30, 2002.

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) 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 Gaff (the Compliance Officer

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

Sincerely,

Dannice Rowland for Alonza E. Cruse

District Director