Abstract
Microbial contamination in non-sterile products (NSPs) presents significant risks to product quality and patient safety. While established regulatory standards delineate specific objectionable microorganisms (OMs), instances of product recalls have revealed broader contaminants requiring examination. Existing pharmacopeial guidelines address a limited number of test organisms, highlighting deficiencies in risk assessment practices. We present the Non-Sterile Product Objectionable Microorganism Dataset (NSPOMdb), which integrates recall data, microbiological characteristics, and risk analysis tools to facilitate the identification and evaluation of potential OMs. This dataset encompasses 1,360 NSP historical recall events and presents a curated list of 89 potential OMs. Each OM entry includes comprehensive annotations on morphological, physiological, biochemical, genomic, and risk-related features. Genomic analysis of 39,626 OM sequences revealed widespread resistance and virulence genes among common contaminants. Furthermore, NSPOMdb provides an online tool ARG-VFG-finder for predicting antimicrobial resistance and virulence genes. NSPOMdb offers a practical framework for improving microbial risk management in the NSP industry.