483
Steriscience Specialties Private LimitedSteriscience Specialties Private Limited – FDA 483, Mar 28, 2024
Record Details
An FDA inspection of Steriscience Specialties Private Limited in Bengaluru, India, revealed significant deficiencies in quality control, manufacturing processes, and record-keeping. The firm released drug products containing rejected API, conducted inadequate investigations into product discrepancies and environmental excursions, and failed to properly train visual inspectors. These issues indicate a systemic lack of adherence to established quality standards for sterile drug manufacturing.
View Company Profile
ID · 9d9699c8-ab22-4b99-8d85-be893a5e8a4a
Other documents for Steriscience Specialties Private Limited
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.