483
Laurus Labs LimitedLaurus Labs Limited – FDA 483, Feb 10, 2023
Record Details
An FDA inspection of Laurus Labs Limited in Visakhapatnam, India, revealed two significant observations. The firm failed to maintain its manufacturing buildings in a clean and sanitary condition, evidenced by black discoloration on a HEPA filter. Additionally, the company did not thoroughly investigate unexplained discrepancies and out-of-specification results related to impurity contamination in drug products during stability studies.
View Company Profile
ID · f55e9f9f-df26-4af2-a33e-4e838000303c
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.