Birchwood Laboratories, Inc. - Jan. 7, 2013
Issue Date
Jan 07, 2013
Region
Central
Category
Drug
$117.00
Address 1
7900 Fuller Rd.
City
Eden Prairie
State
MN
Zip/Postal Code
55344-2138
Country
US
Inspection Range
Jan 03, 2013 - Jan 07, 2013
Pages
1
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): Ivan E. Reyes