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.
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