FDA 483 - CIRON DRUGS AND PHARMACEUTICALS PVT LTD - September 21, 2022

Ciron Drugs and Pharmaceuticals Private Limited, a sterile drug manufacturer in Tarapur, India, received an FDA Form 483 citing significant deficiencies during an inspection. The observations primarily focused on inadequate environmental monitoring in aseptic processing areas, insufficient equipment controls for microorganisms, and a lack of established procedures to prevent microbiological contamination. Additionally, the firm's laboratory controls for handling out-of-specification results were found to be scientifically unsound.