483
Acella Pharmaceuticals, LLCFDA 483 - Acella Pharmaceuticals, LLC - March 29, 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 Acella Pharmaceuticals, Llc in Alpharetta, GA, from March 25-29, 2019, revealed two significant issues related to regulatory reporting. The firm failed to submit annual reports for an approved drug product within the required 60-day timeframe. Additionally, not all annual Periodic Adverse Drug Experience Reports (PADERs) for multiple approved drug products were submitted within 60 days of their respective anniversary dates.
- Office
- Atlanta District Office
- Person
Open in Dashboard
ID · 701617cb-61e5-4e67-a13b-84fc6fd5151b