FDA EIR - Caribe Holdings (Cayman) Co. Ltd dba PuraCap Caribe - July 02, 2021

An FDA inspection of Caribe Holdings (Cayman) Co. Ltd dba PuraCap Caribe, a human drug manufacturer in Dorado, PR, was conducted from June 15 to July 2, 2021. This comprehensive inspection, performed under the Drug Manufacturing Inspections compliance program, focused on Current Good Manufacturing Practices (21 CFR 210/211). The agency identified nine significant objectionable conditions, which were documented on Form FDA 483 and issued to Plant Manager Mr. David Fuster. Key violations included deficiencies in the written stability program, such as not testing drug products in their actual container-closure systems and initiating stability studies before completing quality control tests. Calibration procedures for laboratory instruments were inadequate, and laboratory control mechanisms were not consistently followed, evidenced by incomplete analytical record reviews and insufficient control over access to stability samples. Facilities were not maintained in a good state of repair, and equipment cleaning procedures were deficient. The firm also failed to maintain adequately defined areas for rejected materials, a recurrent observation. Lastly, annual product review procedures were not properly followed. Management acknowledged the observations and committed to providing a written response with corrective actions within fifteen business days. The FDA warned that these conditions could lead to legal sanctions.