Irisys, LLC - April 12, 2021
Issue Date
Apr 12, 2021
Region
Pacific
Category
Drug
$117.00
Contact Name
Robert P. Giannini
Contact Title
President, Chief Scientific and Technical Officer
Address 1
6828 Nancy Ridge Dr.
Address 2
Ste. 100
City
San Diego
State
CA
Zip/Postal Code
92121-2224
Country
United States
Inspection Range
Mar 30, 2021 - Apr 07, 2021
Pages
8
First Observation
Drug product production and control records are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
Investigator(s): Santiago Gallardo Johnson