FDA EIR - Havix Group Inc - January 30, 2019

This FDA Establishment Inspection Report details a pre-announced Surveillance and Pre-Approval Inspection of Havix Group Inc. dba Aavis Pharmaceuticals, located in Hoschton, Georgia. The inspection occurred from January 22 to January 30, 2019, covering their operations as a human drug manufacturer in preparation for their first product intended for the U.S. market, specifically an immediate-release tablet under an Abbreviated New Drug Application (ANDA). The inspection evaluated several key systems, including Quality, Production, Materials, Facilities and Equipment, Laboratory Controls, and Packaging and Labeling. The regulatory framework for this inspection included CPGM 7346.832 (Pre-Approval Inspection) and CPGM 7356.002 (Drug Manufacturing Inspection), along with cGMP regulations (21 CFR 210/211) under the Federal Food, Drug and Cosmetic Act. Crucially, no objectionable conditions were observed, and no FDA Form 483 was issued at the conclusion of the inspection. The firm was found to be in compliance with current Good Manufacturing Practices. While no formal violations or required actions were documented in a Form 483, minor recommendations and outstanding items were noted. These included the need for Aavis Pharmaceuticals to conduct additional testing and justification for environmental swabbing locations in manufacturing rooms, list critical process parameters in bold in batch records, complete qualification for three remaining excipient vendors, and ensure continuous monitoring of all stability chambers by April 2019. The inspection confirmed the firm's readiness for commercial manufacturing and adherence to their application.