Diagnostic Health Center of Texas, L.P. – FDA Warning Letter, Nov 8, 2007
On November 8, 2007, an FDA inspection at Diagnostic Health Center of Texas, L.P. dba Diagnostic Health Arlington revealed serious problems in mammography conduct, violating the Mammography Quality Standards Act of 1992 (MQSA).
The identified violations include: - Missing Phantom Quality Control records from May 30, 2007, through November 7, 2007, for equipment in mammography rooms #1 and #2, violating 21 CFR 900.12(e)(2). - Missing Processor Quality Control records from July 9, 2007, through November 7, 2007, for the film processor, violating 21 CFR 900.12(e)(1).
These deficiencies indicate potential serious underlying issues compromising mammography quality. FDA may take additional actions, including requiring an Additional Mammography Review, implementing a Directed Plan of Correction, charging for on-site monitoring, requiring patient and physician notification of deficiencies, imposing civil money penalties up to $11,000 per violation/day, suspending/revoking the facility's FDA certificate, or seeking a court injunction (42 USC 263b(h)-(j) and 21 CFR 900.120). A Compliance Follow-up Inspection may be performed.
The facility must respond in writing to
ID · 4348325f-e39b-441a-b399-ee781300a4d9
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