Norac, Inc. - April 3, 2009
Issue Date
Apr 03, 2009
Region
Pacific
Category
Drug
$117.00
Address 1
405 S. Motor
City
Azusa
State
CA
Zip/Postal Code
91702
Country
US
Inspection Range
Mar 30, 2009 - Apr 03, 2009
Pages
1
First Observation
Material Qualification activities performed to establish a new supplier of a critical raw material, Sodium Hydroxide (NaOH) in 2005, were deficient in that the initial lots used in the evaluation of the material were manufactured at a facility different from lots subsequently received and used in production. The firm performed full testing on the lots manufactured at a facility to assess the quality attributes and verify the supplier Certificate of Analysis. Subsequent lots manufactured at a facility were not always fully tested. There was no evaluation performed by the firm to demonstrate that the material produced at the manufacturing facility was comparable to the materials.
Investigator(s): Gene Arcy, Thao T. Kwan, and Joey V. Quitania