483
Aphena Pharma Solutions - Tennessee LLCFDA 483 - Aphena Pharma Solutions - Tennessee LLC - November 16, 2017
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 Aphena Pharma Solutions-Tennessee, LLC in Cookeville, TN, a drug packager, revealed significant deficiencies in quality control unit procedures, including inadequate investigations and failure to address environmental excursions. The firm also lacked written procedures for critical production and process controls, and its facility had deficient areas for preventing contamination and mix-ups during packaging operations.
- Person
Open in Dashboard
ID · f11108da-6e65-47d7-88f4-a035e46e5a5b