BAMF Health, Inc. – FDA EIR, Jul 1, 2022

An FDA Pre-Approval inspection of BAMF Health Inc., a Human drug Positron Emission Tomography (PET) manufacturer in Grand Rapids, MI, was conducted from June 27 to July 1, 2022. The inspection, carried out under Compliance Programs 7346.832 and CPGM 7356.002P, identified one significant observation documented on an FDA Form 483. The primary issue was the firm's lack of adequate production and process controls to ensure the consistent quality, identity, strength, and purity of its PET drug product, specifically a violation of 21 CFR 212.50. The key deficiency highlighted was the inadequate environmental monitoring procedure during aseptic manufacturing operations. BAMF Health Inc. failed to perform surface monitoring after each production batch in its ISO 5 Laminar Airflow Hood Workstation. Furthermore, the firm's established action limit for initiating investigations into microbiological contamination was above the acceptable alert levels, resulting in instances of contamination at alert levels not being investigated. This practice demonstrated insufficient controls to assure product quality during aseptic processes. During the closeout meeting, company management acknowledged the observation and agreed to provide a formal written response to the FDA within 15 business days. This response is expected to outline the corrective and preventive actions the company will implement to address the identified deficiencies in their environmental monitoring and overall production controls.