483
Emilia Resources, LLCFDA 483 - Emilia Resources, LLC - August 09, 2019
Discuss this record with AI
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.
Record Details
An FDA inspection of Emilia Resources, LLC, an OTC drug manufacturer in De Kalb, MS, revealed significant deficiencies across multiple areas of their operations. The firm failed to validate manufacturing processes, lacked adequate computer system controls, and did not thoroughly investigate batch failures or ensure proper product release testing. Additionally, issues were noted with supplier qualification and the completeness of annual product reviews.
- Office
- Atlanta District Office
- Person
Open in Dashboard
ID · f65acc30-3e2a-4243-b370-9f363a074afc