FDA 483 - Shine & Pretty USA Corporation - March 04, 2020

Outline & Pretty USA Corporation in Camarillo, CA, a drug manufacturer, was inspected by the FDA and cited for significant deficiencies in quality control. Observations included a lack of written procedures for production, process controls, and change control, as well as failures to investigate unexplained discrepancies in material testing. The firm also maintained an unsuitable facility with cracked floors and unsealed openings, and had deficient instrument calibration procedures.