FDA 483 - SIWA Biotech Corp. - April 27, 2018

SIWA Biotech Corp. in Oklahoma City, OK, an In-Vitro Diagnostic (IVD) Manufacturer, was cited for significant deficiencies in quality oversight, contamination control, and procedural adherence during an FDA inspection. Observations included inadequate potency testing, delayed investigations of Out-of-Specification results, persistent microbial contamination, and a lack of essential SOPs and vendor qualifications. These issues indicate a systemic failure in maintaining proper manufacturing and quality control standards.