Denison Pharmaceuticals, LLC - Feb. 9, 2023
Issue Date
Feb 17, 2023
Region
Northeast
Category
Drug
$117.00
Contact Name
Jose Gaido
Contact Title
President and Chief Executive Officer
Address 1
1 Powder Hill Rd.
City
Lincoln
State
RI
Zip/Postal Code
02865-4407
Inspection Range
Jan 05, 2023 - Feb 09, 2023
Pages
16
First Observation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been aleady distributed.
Investigator(s): Sean R. Marcsisin, Lori M. Newman, and Daniel L. Zheng