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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Advanced Professional Imaging Medical Group 28-Mar-02

Department of Health and Human Services' logoDepartment of Health and 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 28, 2002

Sim Hoffman, M.D.
Medical Director
Advanced Professional Imaging
585 South Knott Avenue
Anaheim, CA 92804-2807

W/L Number: 34-02
Inspection ID: 2200200004
CFN: 20-29,499
FEI: 1000518798

Dear Dr. Hoffman:

We are writing to you because on February 5, 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) [42 U.S.C. § 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 Level 1 finding at your facility:

-Level 1: Processor quality control (QC) records in the month of October 2001 were missing for two (2) out of five (5) operating days that mammograms were developed,in processor #1 (a [redacted] machine, model [redacted] or [redacted] which is located in the darkroom. This is forty percent (40%) of the total time during this month. This is a violation of Title 21 Code of Federal Regulations section 900 .12(d)(2) and 900.12(e)(1).

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 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: The x-ray system for unit #1 (a [redacted] Inc. machine, model [redacted] serial number [redacted], located in the mammography room, does not include compression paddles for two (2) different breast sizes. This is a violation of Title 21 Code of Federal Regulations section 900 .12(b)(8)(ii).

-Level 2: Processor QC records were missing at least two (2) but less than five (5) consecutive days for processor #1 (a [redacted] machine, model [redacted] which is located in the darkroom. This is a violation of Title 21 Code of Federal Regulations section 900.12(e)(1).

-Level 2: Corrective actions for processor QC failures were not documented at least once for processor #1 (a [redacted] machine, model [redacted] which is located in the darkroom. This is a violation of Title 21 Code of Federal Regulations section 900.12(e)(3)(ii).

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: 1-800-838-7715) 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,

/S/

Alonza E. Cruse
District Director

cc:


State of California
Dept. of Health Services
Radiological Management Health Unit
Kathleen A. Kaufman, Director
3530 Wilshire Blvd.; 9th Floor
Los Angeles, CA 90010-2310