FDA 483 - Phoenix Formulations - December 03, 2021

Phoenix Formulations, a dietary supplement manufacturer in Tempe, AZ, was cited for four observations during an FDA inspection. The firm failed to establish adequate product and component specifications for strength, and its quality control personnel did not properly approve or reject processes and tests. Additionally, the company did not use scientifically valid methods for testing and ensuring specifications were met, particularly concerning vendor qualifications and raw material identity and contamination testing.