UC Davis Medical Group-Folsom 17-Jan-02

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

January 17, 2002

Via Federal Express

MQSA Facility ID: 221533

Inspection ID: 2215330003

Katherine Salazar

P.C.N. Manager

UC Davis Medical Group - Folsom

1370 Prairie City Road

Folsom, CA 95630

Dear Ms. Salazar:

We are writing to you because on December 19, 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 United 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 findings at your facility:

1. Processor QC records in the month of 10/2000 were missing for at least 30% of operating days, for processor 1, [redacted] at site UCDMG/Folsom.
2. Processor QC records were missing at least 5 consecutive days for processor 1, [redacted] room Main at site UCDMG/Folsom.

The specific problems noted above appeared on your MQSA Facility Inspection Report,

which was issued to your facility at the close of the inspection. These problems are

identified as Level 1, because they identify a failure to meet a significant MQSA

requirement.

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 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 Carol Blair? s, R.T.M., letter dated January 2, 2002

responding to the Level 1 findings discussed above. Ms. Blair? s response appears to

adequately address the Level 1 findings. 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 (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 Russell Campbell, Compliance

Officer, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA

94502, telephone #: 510-337-6861.

Sincerely yours,

Dennis K. Linsley

District Director