Boehringer Ingelheim Chemicals, Inc. - May 13, 2009
Issue Date
May 13, 2009
Region
Central
Category
Drug
$117.00
Address 1
2820 N. Normandy Dr.
City
Petersburg
State
VA
Zip/Postal Code
23805-9372
Country
US
Inspection Range
Apr 28, 2009 - May 13, 2009
Pages
2
First Observation
Process validation batches manufactured to verify the manufacturing process for X were neither placed on accelerated or long-term stability nor is there documentation to assess the image of the process change on the stability of the product as required per procedure 040-PROC-00381 entitled "The Stability Process".
Investigator(s): Brooke K. Higgins and Joey C. West