FDA WARNING_LETTER - Centro Mas Salud Dr. Gualberto Rabell-Fernandez - July 31, 2017

On July 14, 2017, an FDA inspection at Centro Mas Salud revealed serious violations of the Mammography Quality Standards Act (MQSA). The facility failed to implement systems for timely delivery of medical reports and lay summaries to patients and referring physicians, and for prompt communication of serious or highly suggestive cases, violating 21 CFR 900.12(c)(3)(i),(ii) and 21 CFR 900.12(c)(2)(i),(ii).

The facility's August 11, 2017 response was inadequate, lacking assurance that all reports and summaries would be provided within 30 days, and improperly assigning responsibility to patients for pickup. The response also failed to explicitly state that all mammograms would be read within 30 days and urgent cases communicated promptly.

Additionally, the facility's recordkeeping practices for mammographic images and reports did not comply with 21 CFR 900.12(c)(4), as they improperly shifted record retention responsibility to patients. While the initial training documentation for interpreting physician Gilberto Ramos Pesquera, MD, was previously accepted, the facility's quality control (QC) procedures were found deficient. The technologist performed weekly phantom image QC tests, but the consultant's bi-weekly review was insufficient to ensure compliance with manufacturer recommendations and MQSA regulations, potentially delaying identification of QC failures.

The FDA requires a