Fla. practice cited for serious image quality problems

2019 10 07 17 39 4512 Warning Circular 400

A Florida ob/gyn practice cited for performing mammography without an active certificate has warned patients about serious problems with image quality, according to a new adverse event report from the U.S. Food and Drug Administration (FDA).

The FDA notified Women's Care Florida OB & GYN Specialists from Winter Park in March 2019 that the practice needed to undergo additional mammography review after failing to obtain a Mammography Quality Standards Act (MSQA) certificate extension or American College of Radiology (ACR) accreditation.

In July, the ACR told the FDA that the practice failed the association's review, with 30% of cases not meeting the ACR's image criteria. The ACR then revoked the practice's mammography accreditation, and the FDA suspended its MSQA certificate.

The FDA announced that Women's Care Florida OB & GYN Specialists has since notified at-risk patients about serious image quality deficiencies. The FDA has not yet reinstated the practice's certificate, and the facility is not currently performing mammography.

Page 1 of 568
Next Page