483
SHILPA MEDICARE LIMITEDSHILPA MEDICARE LIMITED – FDA 483, May 29, 2026
Record Details
Shilpa Medicare Limited in Bengaluru, India, a drug manufacturer, was cited for significant deficiencies across its quality systems, including inadequate process validation and failure to thoroughly investigate discrepancies. The firm also lacked complete production records, appropriate controls over computer systems, and proper equipment hold time studies.
- Office
- Office of Partnerships
- Person
View Company Profile
ID · de1fa7e8-f634-4249-9486-7303dfa35287
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.