Haemonetics Corporation - September 18, 2009
Issue Date
Sep 18, 2009
Region
Southeast
Category
Drug
$117.00
Address 1
155 Medical Sciences Dr.
City
Union
State
SC
Zip/Postal Code
29379-8609
Country
US
Inspection Range
Sep 14, 2009 - Sep 18, 2009
Pages
3
First Observation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Tracy R. Ball and Thomas R. Berry