FDA 483 - Biocon Biosphere Limited - June 14, 2024

An FDA inspection conducted at Biocon Biosphere Limited's manufacturing facility in Visakhapatnam, India, from June 10 to June 14, 2024, revealed three significant observations pertaining to regulatory compliance. The primary issue identified was the absence of established written procedures for production and process controls, specifically regarding equipment performance qualification. Several critical pieces of production equipment lacked approved, protocol-driven qualification studies with predefined acceptance criteria and final summary reports, indicating a gap in ensuring equipment suitability for manufacturing processes. Additionally, the inspection noted that in-process materials were not consistently tested for identity, strength, quality, and purity by the quality control unit following extended storage. This poses risks to the quality assurance of materials throughout the production cycle. Furthermore, deficiencies were found in laboratory controls. The microbial enumeration test method validation lacked an appropriate fungal strain, such as Aspergillus brasiliensis, to adequately assess its suitability for mold detection. A raw material specification for a key component also omitted gas chromatography analysis for a specific impurity limit, with relevant material lots not undergoing this analysis. These observations necessitate comprehensive corrective actions by Biocon Biosphere Limited to rectify manufacturing process control, in-process material management, and laboratory testing procedures to ensure product quality and adherence to regulatory standards.