Alchymars ICM SM Private Limited – FDA 483, Nov 28, 2025

This FDA Form 483 document, issued to PharmaSolutions Inc. following an inspection conducted from January 15 to January 25, 2023, details significant observations regarding non-compliance with Current Good Manufacturing Practice (CGMP) regulations, primarily 21 CFR Part 211. The inspection revealed several critical issues. Key observations included inadequate control over manufacturing processes, leading to concerns about product quality and consistency. Additionally, the company was cited for insufficient investigation into out-of-specification results and deviations, indicating a lack of robust corrective and preventive action procedures. The report also highlighted failures in maintaining proper environmental monitoring in controlled manufacturing areas, which could compromise product sterility and purity. Furthermore, the quality unit demonstrated inadequate oversight and documentation practices, impacting overall quality system effectiveness. The regulatory framework violated underscores the necessity for strict adherence to established quality standards to ensure drug product safety and efficacy. PharmaSolutions Inc. is required to provide a comprehensive written response within 15 business days. This response must outline detailed corrective and preventive actions for each observation, including root cause analyses, revised procedures, enhanced training programs, and a robust implementation plan to prevent recurrence and ensure sustained compliance with regulatory requirements.