FDA 483 - TRUECARE BIOMEDIX - February 21, 2025

TrueCare Biomedix, a manufacturing facility located in Gujarat, India, underwent an inspection by the U.S. Food and Drug Administration (FDA) between February 17 and February 21, 2025. The inspection was conducted under the regulatory framework of Section 704(b) of the Federal Food, Drug, and Cosmetic Act to ensure the facility meets quality and safety standards. The primary issue identified by investigators involves the quality control unit"s failure to follow established operating procedures. Specifically, the company did not adhere to its internal protocols for documentation. Investigators found that critical records lacked the required signatures and dates from the employees performing the work. Examples of these omissions were found in the 2023 Stability Sample Location Chart and the 2025 Sample Reconciliation logbooks. These failures demonstrate a lack of consistent oversight in maintaining accurate records of manufacturing and testing activities. To resolve these issues, the firm"s leadership must respond to the FDA with a detailed plan for corrective actions or provide justification for the discrepancies found. This report represents preliminary observations and requires the company to demonstrate how it will improve its documentation and quality management systems to ensure future compliance.