Medisound Inc., 1/22/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	555 Winderley Pl., Ste. 200 Maitland, FI 32751

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-10-09

January 22, 2010

Re: MQSA Inspection ID # 236439

FEI# 3005524110

Alba Garcia, Owner

Medisound, Inc.

301 North John Young Parkway

Kissimmee, Florida 34741

Dear Ms. Garcia:

On November 16, 2009, a representative of the State of Florida, acting on behalf of the Food and Drug Administration (FDA), inspected your facility. The inspection revealed serious problems 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 (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 MQSA violations observed during the current inspection, some of which were also observed during previous inspections on September 7, 2007, and October 10, 2008, were noted on the MQSA Facility Inspection Report and the document "Important Information about Your MQSA Inspection" that Inspector Diane Day left with you at the close of the inspection on November 16, 2009. These violations (referenced below as deviations from the quality standards set forth in Title 21 Code of Federal Regulations Part 900 Section 12 [21 CFR 900.12]) are again identified below.

Noncompliance Level 1

• Failed to produce documents verifying that the radiologic technologist (b)(6) met the initial requirement of holding either a valid state license or a valid certificate from an FDA-approved body. [21 CFR 900.12(a)(2)(i)]

Noncompliance Level 2

• The manufacturer QC procedures for your full field digital mammography (FFDM) device identified as Digital Unit #1, (b)(4) Mammography Room (excluding monitor & printer), were not being followed. This is a repeat violation. [21 CFR 900.12(e)]

• The manufacturer recommended Printer QC procedures for Digital Unit #1, (b)(4) Mammography Room, were not being followed. This is a repeat violation. [21 CFR 900.12(e)]

• Failed to produce documents verifying that the radiologic technologist (b)(6) met the continuing education requirement of having taught or completed at least fifteen (15) continuing education units (CEU's) in mammography in thirty-six (36) months. (b)(6) only had eleven (11) CEU's during this time period. This is a repeat violation. Category 1 continuing medical education (CME) units in mammography in thirty-six (36) months. (b)(6) only had eleven (11) CEU's during this time period. This is a repeat violation. [21 CFR 900.12(a)(2)(iii)]

• The manufacturer recommended QC procedures for the monitor for Digital Unit #1, (b)(4) Mammography Room, were not followed. [21 CFR 900.12(e)]

• The time period between the previous and current surveys for Digital Unit #1 (b)(4) Mammography Room, exceeded fourteen (14) months. [21 CFR 900.12(e)(9)]

• Failed to produce documents verifying that the interpreting physician William Smith met the continuing education requirement of having taught or completed at least fifteen (I 5) Category 1 continuing medical education (CME) units in mammography in thirty-six (36) months. Dr. Smith only had 11.5 CME units during this time period. [21 CFR 900.12(a)(1)(ii)(B)]

• Failed to produce documents verifying that the radiologic technologist (b)(6) met the initial requirement of having forty (40) contact hours of training specific to mammography. [21 CFR 900.12(a)(2)(ii)(A) & (B)]

• Failed to produce documents verifying that the radiologic technologist(b)(6) met the requirement of having eight (8) hours of training in each mammographic modality. [21 CFR 900.12(a)(2)(ii)(C)]

We have received your written response to the MQSA Facility Inspection Report dated December 3, 2009; however, your response is inadequate in that you failed to provide adequate documentation of your corrections.

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; and/or

• 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 the specific steps you have taken, or will take, to correct all of the violations noted in this letter and prevent the recurrence of similar violations, including projected timeframes for implementing those steps.

Please submit your written response to this letter to the attention of Matthew B. Thomaston, Compliance Officer, at the address below.

FDA, Florida District Office

555 Winderley Place, Suite 200

Maitland, FL 32751

Please send a copy of your response to the State of Florida at the address below.

State of Florida, Radiation Control Office

705 Wells Road, Suite 300

Orange Park, FL 33609

Finally, you should understand that there are many requirements pertaining to mammography. This letter pertains only to violations related to the recent inspections 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 contact Michael P. Divine, M.S.,CDRH, at 301-796-5913.

Sincerely,

/s/

 Emma Singleton

Director, Florida District

 

 

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