FDA 483 - Hovione LLC - May 28, 2021

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.