483
Sun Pharmaceutical Industries Ltd.Sun Pharmaceutical Industries Ltd. – FDA 483, Nov 8, 2019
Record Details
Sun Pharmaceutical Industries Ltd. in Baruch, Gujarat, India, received a Form 483 for significant deficiencies in their API manufacturing operations. Observations included inadequate written procedures for testing leading to potential data integrity issues, insufficient investigation and documentation of Out-of-Specification results, and incomplete investigations of quality-related complaints. These issues indicate a lack of robust quality control and data management practices.
View Company Profile
ID · 1b76acf1-0cc6-46a8-bd3d-14c1d7bed7a9
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.