FDA 483 - Healthy Choice Compounding LLC - September 24, 2020

Healthy Choice Compounding LLC was subject to an FDA inspection from September 17 to September 24, 2020, which culminated in a Form FDA 483 outlining significant observations related to their production of non-sterile drug products. The issues identified suggest potential non-compliance with the Federal Food, Drug, and Cosmetic Act, particularly concerning drug quality and manufacturing controls.The inspection revealed several critical deficiencies. Firstly, the company failed to adequately segregate and clean work surfaces and utensils used for hazardous drugs, specifically noting that a capsule machine and non-dedicated equipment were not properly decontaminated between hazardous compounding preparations, posing a risk of cross-contamination. Secondly, Healthy Choice Compounding utilized non-pharmaceutical grade water in compounded drug products without conducting microbial or chemical analyses to ensure its quality. Lastly, the firm released multiple lots of compounded drug preparations that were later found to be out-of-specification for potency. Alarmingly, no recalls were initiated for these dispensed prescriptions despite the confirmed quality deviations.To address these observations, Healthy Choice Compounding LLC is expected to implement comprehensive corrective and preventive actions. These should include establishing rigorous cleaning protocols for hazardous drug handling, qualifying all raw materials, and developing a robust system for managing and recalling out-of-specification drug products to safeguard product quality and patient safety.