FDA 483 - Neutripure Corporation - October 17, 2025

During an inspection from October 15-17, 2025, the FDA issued a Form FDA 483 to Neutripure Corporation, citing significant deficiencies in its manufacturing practices for Over-the-Counter (OTC) and/or homeopathic drug products. The observations primarily highlighted a pervasive lack of an effective quality control unit, which impacted numerous critical operations required under federal drug manufacturing regulations.

Key issues included the absence of defined procedures for receiving, sampling, and testing raw materials, as well as a complete lack of a stability program to support product expiry dates. The company also failed to maintain adequate documentation, such as equipment use and cleaning logs, and master production records were found to be insufficient, missing vital information like raw material quantities and active ingredient potency. Furthermore, there were no formal processes for reviewing production records, managing deviations, or conducting annual product reviews. Employee training, cleaning validation, supplier qualification, and process validation were also notably absent.

The inspection revealed that Neutripure Corporation did not verify the identity of incoming raw materials, relying solely on supplier certificates without independent testing or supplier qualification. Finished drug products were released and distributed without appropriate laboratory testing for identity and strength, with only basic sensory evaluations performed. These observations indicate a significant departure from Current Good Manufacturing Practice (CGMP) regulations, necessitating prompt and comprehensive corrective actions. Neutripure Corporation must establish a robust quality system, implement all missing procedures and testing protocols, validate its manufacturing processes, and ensure thorough documentation and oversight to achieve regulatory compliance.