FDA RESUME - Unknown Company

The FDA conducted an inspection of Apogee Biotechnology Corporation's facility in Exton, PA, from June 19 to 22, 2018. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) regulations for Active Pharmaceutical Ingredients (API), as outlined in Title 21, Code of Federal Regulations, Parts 210 and 211. These violations resulted in the API being classified as adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Key violations identified include the failure to establish and adhere to appropriate written procedures designed to prevent contamination by objectionable microorganisms in non-sterile drug products. Additionally, the firm did not thoroughly investigate discrepancies or failures of batches to meet specifications, nor did it establish adequate written responsibilities and procedures for the quality control unit.

The FDA reviewed Apogee's response dated July 9, 2018, and acknowledged subsequent communications. However, the agency emphasized the need for corrective actions to address these deficiencies. Future FDA inspections and regulatory activities will assess the adequacy and sustainability of the implemented corrections.

The company is required to submit a corrective action plan, including timelines for completion and implementation. This plan should address the deficiencies outlined and ensure compliance with CGMP regulations to prevent further regulatory actions.