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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Redwood Memorial Hospital 7/5/11

  

Department of Health and Human Services logoDepartment of Health and 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

July 5, 2011

Via UPS
Signature Required

Re: MQSA Inspection ID # 1333890017

      FEI# 1000523815  


Joseph Mark
Chief Executive Officer
Redwood Memorial Hospital
3300 Renner Drive
Mammography Dept.
Fortuna, CA 95540

 

Dear Joseph Mark:
 
On April 13, 2011, a representative of the Food and Drug Administration (FDA) inspected your facility. This inspection revealed a serious problem involving the conduct of mammography at your facility. Under the Mammography Quality Standards Act of 1992 ("MQSA"), which is codified in Section 263b of Title 42 of the United States Code (USC), your facility must meet specific requirements to practice mammography. These requirements help protect the health of women by assuring that a facility can perform quality mammography.

The inspection revealed a violation(s) of the MQSA at your facility. These violations were noted on the MQSA Facility Inspection Report and the document "Important Information about Your MQSA Inspection". The violation are again identified below:

Level 2: Two (2) out of ten (10) mammography reports randomly selected for review failed to contain an acceptable assessment category. This is a repeat violation. [21 CFR 900.12(c)]

Level 2:
The manufacturer recommended QC procedures for the monitor for digital unit 4, (b)(4), room Mammography Room were not followed. [21 CFR 900.12(e)]
 
We acknowledge receipt of your written response dated April 14, 2011 to the MQSA Facility Inspection Report. Your response promises to correct the above violations. However, based upon the numerous repeat violations for failure of your mammography reports to contain acceptable assessment categories, we find your response inadequate to assure compliance with MQSA requirements. Failure of mammography reports to contain an acceptable assessment category is a repeat violation that has been reported to you after inspections in July 2008, August 2009 and October 2010. You promised corrections after each of these inspections. 
Because the continued failure to resolve these violations may be indicative of serious underlying problems that could compromise the quality of mammography at your facility, FDA may take additional actions, including, but not limited to, the following:

 

• requiring your facility to undergo an Additional Mammography Review

• placing your facility under a Directed Plan of Correction

• charging your facility for the cost of on-site monitoring

• seeking 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

• seeking to suspend or revoke your facility's FDA certificate

 

See 42 USC 263b(h)-(j) and 21 CFR 900.12(j).


FDA may need to perform a Compliance Follow-up Inspection to determine that each problem at your facility has been corrected.


You should respond in writing to FDA within fifteen (15) working days from the date you received this letter. Your response should address the findings listed above and include:
 

1. the specific steps you have taken, or will take, to correct all of the violations noted in this letter, including projected timeframes for implementing those steps;

2. the specific steps you have taken, or will take, to prevent the recurrence of similar violations, including projected timeframes for implementing those steps;

3. sample records that demonstrate proper record keeping procedures and assessment categories.

 

Note: Patient names or other information that would likely reveal the patient's identity should be deleted from any copies of records you submit
 

Please submit your response to this letter to:
 

Darlene B. Almogela, Director of Compliance 

San Francisco District

U.S. Food and Drug Administration

1431 Harbor Bay Parkway

Alameda, CA 94502


Please send a copy of your response to:

 
State of California
Jerry Hensley, CHP
Chief, X-Ray Inspection, Compliance, and Enforcement
California Department of Public Health
Radiological Health Branch
P.O. Box 997414 MS 7610
Sacramento, CA 95899-7414
 

Finally, you should understand that there are many requirements pertaining to mammography. This letter pertains only to violations related to the recent inspection(s) of your facility 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/cdrh/mammography/index.html. 

 

If you have additional or 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,
/S/
Barbara J. Cassens

District Director

San Francisco District

U.S. Food and Drug Administration