FDA 483 - Fresenius Kabi USA, LLC - June 29, 2018
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.
An FDA inspection of Fresenius Kabi USA, LLC in Grand Island, NY, revealed six observations concerning significant deficiencies in manufacturing controls and quality systems. The firm failed to evaluate material compatibility, maintain complete batch records, and adhere to written procedures for cleaning validation. Additionally, issues were noted with timely Field Alert Report submissions and the quality control unit's written procedures and oversight of contract laboratories.
ID · 073d0262-f2d1-4776-9be6-655e8bbf723d