FDA 483 - Rnv LLC - October 31, 2025

During an FDA inspection conducted from October 27-31, 2025, RNV LLC, an OTC liquid and topical drug manufacturer in Miami Lakes, FL, was cited for several significant deficiencies in its operations. A primary concern, identified as a repeat observation from a 2021 inspection, was the failure to thoroughly review unexplained discrepancies, particularly suspect or out-of-trend test results within the stability program. This included significant variations in assay percentages and atypical microbial counts for various drug products over consecutive timepoints, without proper investigation. Additionally, the inspection revealed shortcomings in production processes. Procedures were not documented contemporaneously, with quality assurance personnel observed pre-filling batch record fields prior to actual weighing activities. Furthermore, major production equipment was not consistently identified, leading to numerous recordkeeping inconsistencies. Examples included unrecorded processing durations, incorrect log entries for materials and equipment, and the lack of readily available or properly documented temperature monitoring equipment. These observations indicate non-compliance with fundamental Good Manufacturing Practices (GMP). RNV LLC is expected to promptly implement comprehensive corrective and preventive actions to address these findings, ensuring the quality, safety, and integrity of its drug products and preventing future recurrences.