FDA EIR - Phoenix Formulations - December 08, 2017

An FDA inspection of Phoenix Formulations, LLC, a contract manufacturer of dietary supplements and meal replacement products in Tempe, AZ, was conducted from December 4-8, 2017. The inspection, performed under the Dietary Supplements and Preventive Controls for Human Food regulatory frameworks, revealed several operational inconsistencies, though no formal FDA 483 was issued. Key observations discussed with management included significant discrepancies between the firm's written Standard Operating Procedures (SOPs) and actual employee practices, particularly in cleaning, sanitation, and personnel hygiene. For instance, employees were observed not following proper handwashing protocols, and encapsulation procedures diverged from documented methods. The inspection also identified issues with the clarity of cleaning schedules, potential for microbial recontamination after in-process testing, and prolonged storage of environmental monitoring swabs, which could affect result accuracy. Furthermore, calibration records showed deviations, and the firm did not consistently verify sanitizer concentrations. Management committed to evaluating and addressing all discussion items and indicated that SOP updates were already underway to align with observed practices and regulatory expectations.