FDA 483 - GoodFibers LLC - August 19, 2022

GoodFibers LLC, an OTC drug manufacturer in Phoenix, AZ, was cited with six observations during an FDA inspection. The firm demonstrated significant deficiencies in its stability program, including a lack of specific test methods and uncontrolled storage conditions for stability samples. Additionally, the inspection revealed failures to investigate out-of-specification results, inadequate laboratory controls for component and finished product testing, and issues with equipment cleaning validation and water system validation.