FDA 483 - Curia India Private Limited - February 16, 2024

An FDA inspection was conducted at Curia India Pvt. Ltd., a drug manufacturer located in Aurangabad, Maharashtra, India, across two periods: February 12-16, 2023, and February 12-16, 2024. The inspection resulted in the issuance of an FDA Form 483, detailing significant observations related to the firm's laboratory methods and procedures. The primary issues identified indicated that the company's practices were not consistently adequate for ensuring product quality and regulatory compliance.

Key observations included: (1) Secondary reference standards were not always prepared by direct comparison to a primary standard, exemplified by a working standard being compared to another working standard. (2) The written procedure for procuring primary standards (SOP-AUR-000188) was deficient, lacking a process for obtaining in-house primary standards for non-compendial products. (3) The Out-of-Specification (OOS) investigation procedure (SOP-AUR-000141) allowed retesting without requiring scientific justification, which could lead to re-analyses without fully addressing the root cause of original OOS results. Curia India Pvt. Ltd. is now required to address these inspectional observations by implementing appropriate corrective and preventive actions to ensure their laboratory operations meet regulatory standards.