Par Formulations Private Limited – FDA 483, Jun 25, 2026

An FDA inspection of Par Formulations Private Limited in Indore, India, a drug manufacturer, revealed two significant observations. The firm failed to perform routine equipment calibration according to a written program, specifically before dismantling and relocating equipment. Additionally, containers and closures were not tested for conformance with written procedures, as records for primary drug product label verification did not document the specific approved artwork used.