WARNING LETTER
Westcoast Radiology, Ltd
MARCS-CMS 554972 —
May 23, 2018
Delivery Method:
United Parcel Service
Reference #:
162487002
Product:
Medical Devices
Recipient:
Recipient Name
Kim Ridley
Westcoast Radiology, Ltd
501 S Lincoln Ave
Clearwater
,
FL
33756
United States
Issuing Office:
Center for Devices and Radiological Health
Office of Medical Device and Radiological Health Operations Division 2 Central
555 Winderley Pl #200
Maitland
,
FL
32751
United States
407-475-4700
Dear Ms. Ridley:
On September 18, 2017, 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 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". The violations are again identified below:
Level 1
: There is no system in place to provide timely medical reports. [See 21 CFR 900.12(c)(3)(i),(ii)].
Level 1
: There is no system in place to provide timely lay summaries. [See 21 CFR 900.12(c)(2)(i),(ii)]
Level 1
: There is no system in place to communicate serious or highly suggestive cases as soon as possible. [See 21 CFR 900.12(c)(3)(ii)]
You have failed to respond to the MQSA Facility Inspection Report as requested in the document "Important Information about your MQSA Inspection" emailed to you on October 25, 2017.
Because the continued failure to resolve this (these) violation(s) 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
•           requiring your facility to notify patients who received mammograms at your facility, and their referring physicians, of the deficiencies, the potential harm resulting from such deficiencies, appropriate remedial measures, and other relevant information
•           seeking civil money penalties up to $11,000 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)]
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.
Note:
Patient names or other information that would likely reveal the patient's identity can be deleted from any copies of records you submit.
Please submit your response to this letter to Compliance Officer, Andrea Norwood at oradevices2firmresponses@fda.hhs.gov
Please send a copy of your response to:
Bureau of Radiation Control/Mammography Division
4052 Bald Cypress Way Bin C21
Tallahassee, FL 32399-1741
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/Mammography.
Should you have questions concerning the content of this letter, please direct your questions to Karen Smallwood, Radiological Health Representative, telephone number 615-366-7823.
Sincerely,
/S/
Blake Bevill, MS
Program Division Director
Office of Medical Device and Radiological Health
Division 2 – Central
cc:
Nicholas Pospishil
Radiation Control
2044 All Childrens Way
Orlando, FL 32818
Content current as of:
05/29/2018
Regulated Product(s)
Medical Devices