Hovione, LLC - May 28, 2021
Issue Date
May 28, 2021
Region
Central
Category
Drug
$117.00
Contact Name
Filipe Tomas
Contact Title
General Manager
Address 1
40 Lake Dr.
City
East Windsor
State
NJ
Zip/Postal Code
08520-5321
Country
United States
Inspection Range
May 10, 2021 - May 28, 2021
Pages
23
First Observation
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drug product.
Investigator(s): Saleem A. Akhtar, Robin P. Mathew, Annet R. Rajan, and Stelios C. Tsinontides