FDA EIR - Brooks Life Sciences - August 21, 2015

An FDA inspection of Pacific Bio-Material Management, Inc., a licensed storage and distribution facility for plasma, was conducted from August 20-21, 2015. This initial comprehensive inspection, part of the Los Angeles District workplan and guided by C.P. 7342.001 for blood bank inspections, aimed to assess the facility’s storage and distribution practices. While no formal violations (FDA-483 observations) were issued, the inspection identified two key areas for improvement. First, the facility lacked a clear system to distinguish whether stored plasma was designated for further manufacturing, testing, or commercial/human use, which could impact product traceability and recall efficiency. Second, daily Quality Control thermometer checks for storage units were not being performed. In response, the company’s Director of Quality agreed to implement necessary changes, including updating customer contracts to specify the intended use of stored products and establishing a routine for daily thermometer checks and record-keeping to ensure proper environmental conditions. The firm functions as a repository for materials, primarily from research and development and academia, and does not take ownership of the stored items.