FDA 483 - Hovione LLC - May 28, 2021
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.
Hovione LLC in East Windsor, NJ, was inspected and received a Form 483 with eight observations primarily concerning manufacturing controls, laboratory practices, and quality system deficiencies. The inspection revealed issues with equipment maintenance, API testing, data integrity in laboratory records, adherence to production procedures, and inadequate investigation of quality incidents. Additionally, deficiencies were noted in employee GMP training and the warehousing and handling of raw materials.
ID · 18fc6b6f-89e5-47a6-8bf8-079e0a660ac4