FDA 483 - Vintage Chemical, Inc. - April 12, 2023

Vintage Chemical, Inc. in Fort Wayne, IN, received a Form 483 following a GMP surveillance inspection, revealing significant deficiencies in their manufacturing operations. The firm lacked written procedures for equipment cleaning and maintenance, as well as for packaging and labeling operations. Additionally, the inspection found failures in conducting identity testing for incoming raw materials and components, and an over-reliance on unvalidated supplier certificates of analysis.