FDA WARNING_LETTER - East Jefferson General Hospital IRB - January 08, 2019

On January 8, 2019, an FDA inspection of the facility revealed serious MQSA violations. Specifically, x-ray units 98 and 12 in Mammography 3 were not accredited, violating 21 CFR Part 900.4(a), (b) & (c)(4). This was a repeat Level 2 violation from a December 8, 2016 inspection.

The facility failed to respond adequately to the initial inspection report, necessitating a "No Response Letter" on March 20, 2019. A subsequent email response on June 5, 2019, was deemed inadequate as it provided a corrective action plan from the 2016 inspection, indicating insufficient preventive actions. An "inadequate response letter" was sent on July 29, 2019, requesting a new response within 21 days, which was not received.

The FDA warns of potential further actions, including an Additional Mammography Review, a Directed Plan of Correction, charges for monitoring, patient/physician notification, civil money penalties up to $11,000 per violation/day, and suspension or revocation of the facility's FDA certificate.

The facility must respond in writing within 15 working days, detailing specific corrective and preventive actions with timeframes, and providing sample record-keeping procedures. The response should be sent to Compliance Officer Andrea Norwood