FDA EIR - Brooks Life Sciences - November 29, 2016

An FDA inspection of Pacific Bio-Material Management, Inc. (PBMMI) in El Segundo, CA, took place on November 29, 2016. This comprehensive Level 1 inspection reviewed the facility's operations as a storage and distribution center for biological materials, including blood, plasma, and human tissue specimens, as well as human allograft tissue. The inspection was conducted under FDA compliance programs for blood banks, reference laboratories, contractors, and human cells, tissues, and cellular and tissue-based products (HCT/Ps). The inspection concluded with a "No Action Indicated" (NAI) classification, signifying that no significant regulatory violations were found. As a result, an FDA Form 483 (Inspectional Observations) was not issued to the company's management, and no specific regulatory actions were required from the FDA. The report noted PBMMI's established temperature monitoring system and a comprehensive three-part employee training program, ensuring personnel competence and quality assurance.