Radiological Associates of Sacramento Medical Group, Inc. 05-Sep-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

San Francisco District

1431 Harbor Bay Parkway

Alameda, CA 94502-7070

Telephone: 510-337-6700

WARNING LETTER

September 5, 2001

Via Federal Express

MQSA Facility ID: 148932

Inspection ID: 1489320007

Nancy Reed, Director of Operations

Radiological Associates Of Sacramento Medical Group, Inc.

2 Scripps Drive Suite 110

Sacramento, CA 95825

Dear Nancy Reed:

We are writing to you because on August 16, 2001, your facility was inspected by a

representative of the State of California, acting in behalf of the Food and Drug

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

the mammography at your facility.

Under a Limited States Federal law, the mammography Quality Standards Act of 1992,

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 QC records were missing for at least 4 weeks for unit 4, [redacted]

Room [redacted] ROOM

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, 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.

We acknowledge receipt of Jan Curry?s, Site Supervisor, letter dated August 23, 2001

responding to the Level 1 finding discussed above. Ms. Curry?s response appears to

adequately address the Level 1 finding. Your corrective actions will be verified during

the next inspection.

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 (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 contact Russell A. Campbell, Compliance Officer, at 510-337-6861.

Sincerely yours,

Dennis K. Linsley

District Director