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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Centro Estudios Radiologicos - Santurce Medical Mall 4/4/06

   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

San Juan District
Compliance Branch
466 Fernandez Juncos Avenue
San Juan, Puerto Rico 00901·3223
Telephone: 781-474-9500
FAX: 787-729-6658 


April 4, 2006


WARNING LETTER
SJN-06-07


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


William Cruz, M.D.
Centro Estudios Radiologicos - Santurce Medical Mall
Santurce Medical Mall
Ponce De Leon, 1801, Oficina 201, Parada
Santurce, PR 00909

FACILITY ID
# 2266140004


Dear Dr. Cruz
 


On 12/16/2005, investigators of the Food and Drug Administration (FDA), inspected your mammography facility, Centro Estudios Radiologicos-Santurce Medical Mall located at Santurce, PR. This inspection revealed a significant regulatory problem involving the mammography at your facility. Under United States federal law, the Mammography Quality Standards Act (MQSA) of 1992 [42 U.S.C. 263b], 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 violations 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" that the investigators left with your facility management at the close of the inspection. The violations are again identified below.

Level 1: (b)(4) records were missing for at least 4 weeks for unit 1, (b)(4) room Mammography Room. [21 CFR 900.12(e)(2)]


Level 1: (b)(4) records in the month of 03/2005 were missing for at least 30% of operating days, for processor (b)(4) room DARKROOM. [21 CFR 900.12(e)]


The specific problems noted above appeared on your MQSA Facility Inspection Report, which was issued to your facility at the close of the inspection on 12/20/2005. These problems are identified as Level 1, because they identify a failure to meet a significant MQSA requirement. In addition, the following Level 2 deficiencies were found during the inspection:


Level 2: Corrective action before further exams, for a failing image score, or a phantom background optical density, or density difference outside the allowable regulatory limits, was not documented for unit (b)(4) room Mammography Room as required by 21 CFR 900.12 (8)(ii).

Level 2: (b)(4) records were missing at least 2 but less than 5 consecutive days for processor (b)(4) room DARKROOM at site Centro Estudios Radiologicos - Santurce Medical Mall. [21 CFR 900.12(e)]

Level 2: (b)(4) Corrective action for (b)(4) failures were not documented at least once for processor (b)(4) room DARKROOM at site Centro Estudios Radiologicos - Santurce Medical Mall. [21 CFR 900.12 (10).
 

Level 2: The mammography processor equipment evaluation (by a medical physicist) for processor (b)(4) room DARKROOM, site Centro Estudios Radiologicos - Santurce Medical Mall was not performed as required by 21 CFR 900.12(10).


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
• seeking a court injunction against your facility.


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


We received your two written responses addressing the findings of this inspection on January 17, 2006 and February 9, 2006, respectively. Your first response was found inadequate because the proposed corrective actions did not address the level 1 deficiencies found during the inspection. In addition, the letter lacked the date and signature of the most responsible person of your facility. Although your second response addressed all the deficiencies found during the inspection, you must adequately implement and maintain each corrective action to ensure its effectiveness.


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 indicate if you have implemented all the corrective actions indicated in your February 9, 2006 letter and/or projected timeframes for implementing those steps.


Please submit your response to Food and Drug Administration, Attention: Ms. Margarita Santiago, Compliance Officer, at 466 Fernandez Juncos Avenue, San Juan, PR 00901.


Finally, you should understand that there are many FDA requirements pertaining to mammography. This letter pertains only to findings disclosed during the inspection 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.


Sincerely,
/S/

Maridalia Torres