FDA 483 - SV Labs Prescott Corporation - June 13, 2025

SV Labs Prescott Corporation received a Form 483 with 14 observations, primarily citing significant deficiencies in their manufacturing and quality control operations for OTC finished drug products. Key issues include a complete lack of process validation, the release of out-of-specification products, and inadequate laboratory controls for microbial testing and investigations. The firm also demonstrated poor record-keeping, insufficient equipment qualification, and a lack of proper personnel training, with some issues being repeat observations.