FDA 483 - R & B Medical Group Inc. - September 25, 2019

B C Medical Group Inc. in Van Nuys, CA, an RCDAD Testing Laboratory, was cited for significant deficiencies in its quality program and testing procedures during an FDA inspection. Observations included a lack of a quality program to manage deviations, absence of written procedures for HCT/P manufacturing steps, and failure to follow manufacturer's instructions for communicable disease testing. Additionally, the firm's record-keeping and personnel oversight were found to be inadequate, with incomplete and unreviewed testing documents and insufficient staff for proper supervision.