FDA EIR - ATUL Limited - December 13, 2024

An FDA Current Good Manufacturing Practice (CGMP) surveillance inspection of ATUL Limited, an active pharmaceutical ingredient (API) manufacturer located in Valsad, Gujarat, India, was conducted from December 9 to December 13, 2024. This inspection was part of the FY2025 Foreign Drug Inspection workplan, following Compliance Program 7356.002F for Active Pharmaceutical Ingredient Process Inspection and ICH Q7 Good Manufacturing Practice Guidance. The comprehensive inspection covered the company's Quality, Production, Facilities and Equipment, Materials, Laboratory Control, and Packaging and Labeling systems. Notably, at the conclusion of the inspection, no FDA Form 483, Inspectional Observations, was issued, indicating no significant violations were found. The inspection was classified as "No Action Indicated" (NAI). Furthermore, the FDA verified that corrective actions previously implemented by ATUL Limited to address three verbal observations from a 2016 inspection were adequate. These prior observations related to insufficient documentation of batch record amounts, general documentation practices, and inadequate supporting documentation for complaint file closures. As a result of the current inspection's findings, no specific required actions were mandated for ATUL Limited, although a re-inspection is noted for future consideration based on CDER risk assessment.