483
Sun Pharmaceutical Industries Limited- MadhuranthagamSun Pharmaceutical Industries Limited- Madhuranthagam – FDA 483, Feb 17, 2023
Record Details
An FDA inspection of Sun Pharmaceutical Industries Limited- Madhuranthagam, an API manufacturer, revealed that laboratory testing was not performed under controlled conditions. Specifically, the firm failed to maintain required humidity control during the handling and testing of a highly hygroscopic API and lacked adequate procedures to minimize environmental exposure during multiple tests. This indicates a significant lapse in quality control for critical product testing.
- Inspection date
- February 17, 2023
- Product type
- drugs
View Company Profile
ID · e472bee1-f895-4350-9a35-fc521fb744f9
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.