American Red Cross Diagnostic Manufacturing Division
Issue Date
Dec 04, 2009
Region
Central
Category
Drug
$117.00
Address 1
9319 Gaither Rd.
City
Gaithersburg
State
MD
Zip/Postal Code
20877-1417
Country
US
Inspection Range
Nov 30, 2009 - Dec 04, 2009
Pages
3
First Observation
Process control procedures that describe any process controls necessary to ensure conformance to specifications were not established and documented.
Investigator(s): Burnell M. Henry and Helen B. Ricalde