FDA 483 - Pacifica Pharmacy - September 09, 2019

Pacifica Pharmacy in Torrance, CA, underwent an FDA inspection from August 26 to September 9, 2019, which resulted in the issuance of an FDA Form 483. The inspection highlighted significant concerns regarding the firm's compounding practices, particularly related to product quality and safety. Two main observations were documented. Firstly, the pharmacy was cited for inadequate cleaning procedures for work surfaces and utensils, especially when handling hazardous drugs. The cleaning methods employed were deemed insufficient to prevent cross-contamination between hazardous and non-hazardous compounds, and visible particle buildup was noted in compounding hoods and on equipment. This raises concerns about potential contamination risks for drug products. Secondly, the FDA observed the use of a non-pharmaceutical grade component in drug formulations. Specifically, an expired lot of Vitamin A Palmitate in Almond Oil, which was also improperly stored at room temperature instead of refrigerated, was used in 21 different prescription products. These observations indicate potential violations of quality control standards expected from compounding pharmacies. Pacifica Pharmacy is required to respond to the FDA with a comprehensive plan outlining corrective actions to address these deficiencies and ensure compliance with regulatory requirements, thereby safeguarding patient safety and product integrity.