Flourish Integrative Pharmacy, LLC – FDA 483, Dec 19, 2018

An FDA inspection conducted from December 11-19, 2018, at Flourish Integrative Pharmacy, LLC, identified significant deficiencies in their production of non-sterile drugs. The inspection revealed three primary observations. First, the company failed to test water components for conformity to appropriate specifications for purity, strength, and quality, including a lack of analytical or microbiological testing to ensure it met Purified Water, USP standards for use in various drug products. Second, Flourish Integrative Pharmacy lacked a written stability testing program necessary to establish and justify Beyond Use Dates (BUDs) for their drug products. Specific examples of compounded products with unsubstantiated BUDs were cited. Third, the firm did not routinely conduct laboratory testing to determine the identity and strength of active ingredients in all drug products before release for distribution. These observations indicate non-compliance with fundamental quality control principles for drug manufacturing. The company is required to provide a formal response to the FDA, detailing the corrective actions they have taken or plan to take to address these critical issues.