Reliable Biopharmaceutical Corp - March 24, 2010
Issue Date
Mar 24, 2010
Region
Southwest
Category
Drug
$117.00
Address 1
1945 Walton Rd.
City
St. Louis
State
MO
Zip/Postal Code
63114
Country
US
Inspection Range
Mar 17, 2010 - Mar 24, 2010
Pages
1
First Observation
Retrospective process revalidation was deficient for your Active Pharmaceutical Ingredient batches that were used for revalidation although the corrective actions, which included changes in equipment and temperature, were not yet implemented in these batches.
Investigator(s): Sherry G. Bous