483
Dr. Reddy's Laboratories LtdDr. Reddy's Laboratories Ltd – FDA 483, Oct 25, 2019
Record Details
An FDA inspection of Dr. Reddy's Laboratories Ltd CTO SEZ Process Unit-01, an API manufacturer, revealed significant deficiencies. Observations included inadequate investigations into potential root causes, insufficient evaluation of cleaning processes for non-dedicated equipment, and improper storage of production equipment. Additionally, the Quality Unit demonstrated a lack of oversight regarding manufacturing equipment.
View Company Profile
ID · c94c592f-e352-4715-99c3-c7675e634671
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.