FDA EIR - Kobo Products, Inc - August 18, 2020

An FDA inspection of Kobo Products, Inc., a manufacturer of Active Pharmaceutical Ingredients (APIs) for OTC sunscreen and cosmetic products, was conducted from August 10-18, 2020. The inspection aimed to provide cGMP coverage, adhering to regulatory frameworks such as CP7356.002F and Q7A Good Manufacturing Practice Guidance for APIs. The inspection identified significant and recurring deficiencies, resulting in an FDA-483. Key violations included the failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of microbiology test methods, such as suitability testing and growth promotion. This was a repeat observation from previous inspections in 2010, 2013, and 2015. Furthermore, the company demonstrated inadequate controls over laboratory computer systems, exemplified by shared user access for analytical instruments, insufficient data protection against alteration or deletion, and a lack of qualification for critical equipment like Particle Size Analyzers, X-ray Fluorescence, and Gas Chromatographs. These issues were also repeat observations. Laboratory records were found to be incomplete, lacking essential details such as analytical formulas, instrument identification, and conformance statements for tests performed, another recurring deficiency. Company management acknowledged the deficiencies and committed to providing a written response with corrective actions within 15 business days, with some actions initiated during the inspection. The expectation is comprehensive remediation to ensure full compliance with cGMP regulations.