SHIMOGA CHEMICALS – FDA 483, Jan 23, 2026

Shimoga Chemicals, an API manufacturer in Sangli, India, was cited for numerous severe deficiencies during an FDA inspection. The findings highlight systemic data integrity issues in laboratory controls and batch records, inadequate process validation, poor equipment cleaning and maintenance, insufficient stability data, and a complete lack of thorough investigations into discrepancies and OOS results. These observations indicate a significant failure to adhere to cGMP requirements across multiple critical areas of drug manufacturing.