The U.S. Food and Drug Administration inspected Aspen Biopharma Labs Private Limited, drug facility; at Rangareddy region from September 16 to September 21, 2024. And they get a warning letter which summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API).
FDA noted that the company failed to design and construct buildings and facilities used in the manufacture of your API in a manner to minimize potential contamination, facilitate appropriate cleaning, maintenance, and operations.
FDA also noted that Aspen Biopharma Labs failed to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes and failure to adequately validate written procedures for the cleaning and maintenance of equipment.
On January 14, 2025, FDA held a teleconference with the company and recommended it to consider removing any lots of drugs currently in distribution from the U.S. market. On January 16, 2025, the company agreed to voluntary recall of all drugs in current distribution in the United States and it initiated a voluntary nationwide recall on February 7, 2025, of all products distributed in the United States.
FDA recommended based upon the nature of the deviations, the company should engage a consultant qualified to evaluate its operations and to assist the firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of the company's corrective actions and preventive actions before it pursues resolution of compliance status with FDA.
