PrimaPharm, Inc. - Sept. 11, 2009
Issue Date
Sep 11, 2009
Region
Pacific
Category
Drug
$117.00
Address 1
3443 Tripp Ct.
City
San Diego
State
CA
Zip/Postal Code
92121
Country
US
Inspection Range
Aug 24, 2009 - Sep 11, 2009
Pages
11
First Observation
The firm failed to investigate HEPA filter/clean room certification failures throughout the facility where sterile injectable drug products are manufactured.
Investigator(s): Jennifer M. Gogley, Caryn M. McNab, Joey V. Quitania, and Nelly N. Tran