FDA 483 - Tianish Laboratories Private Limited - November 07, 2025

An FDA inspection of Matrix Pharmacorp Private Limited, an Active Pharmaceutical Ingredient (API) manufacturer in Visakhapatnam, India, revealed two significant observations. The firm failed to ensure proper cleaning of production equipment, leading to residue and potential contamination of APIs. Additionally, the Quality Control Unit did not thoroughly investigate consumer complaints regarding mold contamination in finished API products, failing to determine a definitive root cause.