FDA 483 - Ceevra Inc. - August 26, 2024

Ceevra Inc., a manufacturer of Class II medical imaging devices in San Francisco, CA, was cited for deficiencies in its complaint handling procedures. The firm failed to ensure timely completion of Medical Device Report (MDR) determinations for complaints, with significant delays noted in two specific cases. These delays could potentially impact patient surgery outcomes and the firm's ability to report adverse events to the FDA in a timely manner.