FDA WARNING_LETTER - Redwood Memorial Hospital - April 13, 2011

On April 13, 2011, the FDA inspected Redwood Memorial Hospital, revealing serious mammography quality issues. The inspection identified two Level 2 violations of the Mammography Quality Standards Act (MQSA), codified in 42 USC 263b.

Firstly, two out of ten randomly selected mammography reports lacked an acceptable assessment category, a repeat violation of 21 CFR 900.12(c) previously cited in July 2008, August 2009, and October 2010. Secondly, the facility failed to follow manufacturer-recommended QC procedures for the monitor of digital unit 4, violating 21 CFR 900.12(e).

The hospital's April 14, 2011, response promising corrections was deemed inadequate due to the persistent nature of the assessment category violation. The FDA warned that continued non-compliance could lead to severe actions, including an Additional Mammography Review, a Directed Plan of Correction, charges for on-site monitoring, civil money penalties up to $10,000 per violation/day, or suspension/revocation of the facility's FDA certificate (42 USC 263b(h)-(j) and 21 CFR 900.12(j)).

Redwood Memorial Hospital must respond in writing within fifteen working days, detailing specific corrective and preventative steps with