Kedrion Biopharma, Inc. - June 25, 2021
Issue Date
Jun 25, 2021
Region
Northeast
Category
Drug
$117.00
Contact Name
Tommaso Paoli
Contact Title
Site Lead
Address 1
155 Duryea Rd.
City
Melville
State
NY
Zip/Postal Code
11747-3835
Country
United States
Inspection Range
Jun 14, 2021 - Jun 25, 2021
Pages
2
First Observation
During the walk through of the facility on June 14, 2021 the following deficiencies were noted: ... Buffer Prep Tank ... was observed to have free white powdery substance on the external surface of the tank opening (near the hinge).
Investigator(s): David Galler-Veety, Burnell M. Henry, Susan M. Jackson, and Ann M. Stewart