FDA 483 - SAB Herbals and Nutraceuticals - November 22, 2024

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from November 18-22, 2024, at SAB Herbals and Nutraceuticals in Udham Singh Nagar, India, several significant observations were noted, detailed in a Form FDA 483. This document highlights potential deviations from current Good Manufacturing Practices (cGMP) for drug product manufacturing. The primary issues revolved around inadequate laboratory controls and quality assurance processes. Specifically, the firm was cited for not establishing scientifically sound specifications and test procedures for components and in-process materials. For example, an impurity profile assessment was absent for a key raw material used in multiple manufacturing cycles. Additionally, the company failed to perform essential growth promotion tests on in-house culture media prior to using them for microbial testing of finished API products, which is crucial for ensuring test validity. Furthermore, the inspection revealed that the responsibilities and procedures for the quality control unit, particularly concerning growth promotion testing, were not formally documented in writing. There was also a failure to conduct specific identification and assay tests on incoming batches of critical components, such as a bulk material used in API production, relying instead solely on supplier reports. These observations indicate a need for SAB Herbals and Nutraceuticals to implement robust corrective actions. The firm is expected to address these deficiencies to ensure compliance with cGMP regulations, thereby safeguarding the identity, strength, quality, and purity of its drug products.