Food and Drug Administration

19900 MacArthur Blvd., Ste 300

Irvine, California 92612-2445

Telephone (949) 798-7600

WARNING LETTER

October 21, 2002

W/L Number: 03 - 03

Inspection ID: 1748050008

CFN: 20-29,926

FEI: 1000519057

FACTS: 15181-0

Certified Mail

Return Receipt Requested

Traci Imbrogno

Radiology Supervisor

Taibert Medical Group - Huntington Beach

19066 Magnolia Street

Huntington Beach, CA 92646-2232

Dear Ms Imbrogno:

We are writing to you because on September 24, 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 compromise in the quality of the mammography services offered by your facility.

Under the Mammography Quality Standards Act of 1992 (MQSA), 42 U.S.C. 263b, and the Quality Standards for Mammography set forth in Title 21, Code of Federal Regulations (C.F.R.), Part 900, 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 your facility revealed the following Level 1 violation and Level 2 violation:

Level 1 - Phantom quality control (QC) records were missing for at least 4 weeks for unit #3 (a [redacted] machine, model [redacted], serial number [redacted], which is located in the mammography room. This is a violation of Title 21, Code of Federal Regulations, section 900.12(e)(2).

Level 2 - Failed to produce documents verifying that the radiologic technologist, [redacted] (12 continuing educations units [ CEU?s ] in thirty-six [ 36 ] months), met the continuing education requirement of having taught or completed at least fifteen (15) continuing education units in mammography in thirty-six (36) months. This is a violation of Title 21, Code of Federal Regulations, section 900.12(a)(2)(iii)(A).

The specific problems noted above appeared on your MQSA Facility Inspection Report, which was issued to your facility at the close of the inspection. Because these conditions may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility, they represent a serious violation of the law that may result in FDA taking regulatory action. These actions include, but are not limited to, placing your facility under a Directed Plan of Correction DPC) and/or charging your facility for the cost of on-site monitoring. Failure to correct these violations promptly could also cause FDA to seek civil money penalties of 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 seeking a court injunction against performing further mammography (see 42 U.S.C. 263b(h) through (j) of the MQSA).

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; and

- please submit 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).

In accordance with Title 21, Code of Federal Regulations, section 900.12(a)(2)(iii)(D), radiologic technologists who fail to meet the continuing education requirements may not resume performing unsupervised mammography examinations until the continuing education requirements are completed. In your written response, please assure us that this radiologic technologist is not performing unsupervised mammography examinations until her continuing education requirements are completed.

Please submit your response to:

Thomas L. Sawyer

Director, Compliance Branch

U.S. Food & Drug Administration

19900 MacArthur Blvd.; Suite #300

Irvine, CA 926 12-2445

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 recent 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: 1-800-838-7715) or through the Internet at http://www.fda.gov/cdrh/mammography.

If you have more specific questions about mammography facility requirements or about the content of this letter, please feel free to contact Scott Goff (the Compliance Officer assigned to this case) at telephone number 949-798-7644.

Sincerely,

/s/

Alonza E. Cruse

District Director