FDA 483 - Grandpa's Compounding Pharmacy, Inc. - September 18, 2015

During an inspection conducted from September 3 to September 18, 2015, the Food and Drug Administration (FDA) identified significant deficiencies at Grandpa's Compounding Pharmacy, Inc. The inspection revealed two primary violations of good manufacturing practices. Firstly, the firm failed to reject drug components that did not meet appropriate written specifications. Specifically, Domperidone powder labeled "NOT FOR HUMAN USE" was utilized to produce Domperidone capsules for human consumption, leading to the dispensing of thousands of prescriptions between May 2014 and April 2015. This constitutes a serious breach of quality control. Secondly, the pharmacy did not consistently follow its own standard operating procedures for handling written and oral complaints regarding drug products. A notable instance involved a patient complaint about potential contamination of progesterone lozenges, which was neither adequately documented nor thoroughly investigated by contacting the patient, despite the firm's SOP requiring such actions. These observations indicate a need for the firm to implement robust corrective actions to ensure proper component control and effective complaint management, adhering to regulatory standards for drug product quality and safety.