FDA 483 - Tianish Laboratories Private Limited - November 07, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 4cfdfa6f-323f-40b2-a6cc-9106bd18b0fc