FDA 483 - Valens Molecules Private Limited - September 13, 2024

Valens Molecules Private Limited Unit - II, an Active Pharmaceutical Ingredient (API) manufacturer located in Hyderabad, Telangana, India, was subject to an FDA inspection from September 9 to September 13, 2024. The inspection concluded with the issuance of a Form FDA 483, identifying significant deficiencies in the firm's laboratory controls and quality assurance processes. The primary concern was the lack of scientifically sound and appropriate test procedures to confirm that drug substances meet required standards for identity, strength, quality, and purity. Specifically, the FDA observed that Valens Molecules failed to perform necessary assay testing for certain USP drug substances before their subsequent use. Additionally, the firm utilized non-validated methods for preparing microbiological media, which is critical for USP <61> Microbial Enumeration Tests and USP <62> Tests for Specified Microorganisms. Compounding this, growth promotion testing was not consistently conducted on each lot of this in-house prepared media, thereby compromising the reliability of microbial analyses. These observations indicate a need for Valens Molecules to enhance its laboratory control systems to ensure full compliance with Current Good Manufacturing Practices (CGMP). The company is expected to provide a comprehensive response to the FDA outlining its corrective actions to address these findings.