FDA 483 - Emcure Pharmaceuticals Limited - February 25, 2025

Emcure Pharmaceuticals Limited, an API manufacturer in Pune, Maharashtra, India, was issued a Form 483 following an inspection from February 19-25, 2025. The inspection revealed significant deficiencies in equipment cleaning, cleaning validation, and maintenance procedures, including visible residues and improper use of materials. Additionally, the firm failed to adequately document and verify training records for personnel involved in manufacturing and cGMP.