Genus Lifesciences Inc. – FDA EIR, Jul 31, 2024

An abbreviated surveillance Current Good Manufacturing Practices (CGMP) inspection of Genus Lifesciences Inc., located in Allentown, PA, was conducted by the FDA from July 29 to July 31, 2024. This inspection, part of the FY24 work plan, aimed to provide surveillance coverage for drug products manufactured by the firm, specifically covering liquid and powder profiles, under the regulatory framework of CPGM 7356.002, Drug Manufacturing Inspections. Crucially, the current inspection concluded without any objectionable conditions or issuance of an FDA Form 483, Inspectional Observations, indicating that the facility was found to be in compliance with CGMP regulations during this assessment. In contrast, a previous FDA inspection conducted from September 9 to September 20, 2019, had resulted in a 3-item FDA Form 483. The main issues identified then included inadequate review of unexplained discrepancies, insufficient written procedures for production and process controls, and failure to timely submit NDA-Field Alert Reports. The current report indicates that voluntary corrections made by Genus Lifesciences Inc. in response to the previous inspection were reviewed and no significant deficiencies were noted. Therefore, no new specific required actions were issued as a result of the 2024 inspection.