483
AET Laboratories Private LimitedFDA 483 - AET Laboratories Private Limited - February 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.
Record Details
AET Laboratories Private Limited, a drug manufacturer in Hyderabad, India, received a Form 483 with a repeat observation concerning inadequate equipment cleaning and maintenance. Inspectors noted frayed edges, rust, rough welds, and surface abrasions on manufacturing equipment used for commercial drug products, some of which were distributed to the United States. This indicates a persistent failure to prevent contamination and ensure drug product quality.
Open in Dashboard
ID · aeaadd73-a62b-4b32-88e5-3631321f3a29