PDF file (240 KB)
Searle, Ltd., 2002-12-27
"During the validation of the manufacturing process for Plaquenil, two of the validation lots had out of specification results for the hardness test. However, in your validation report you concluded that lots xxxxx were in compliance because low hardness result tablets pass friability and high hardness result tablets pass dissolution testing. You are also accepting hardness results outside your established specifications for routine manufacturing process."

PDF file (376 KB)
Neil Laboratories Inc., 2001-10-02
"Your firm averages Out-of-Specification (00S) dissolution results with test data results that are within specification."
"Procedure for Dissolution Apparatus Calibration Method 002A does not require testing for physical attributes of the bath. The procedure does not assess wobble during calibration"
"Stability Method is stability indicating in that the method does not contain predetermined dissolution specifications."
"Aspirin E/C 325 mg Tablets Method does not have predetermined specifications for percentage of Acid during the Acid Stage dissolution."

PDF file (520 KB)
Kiel Laboratories, Inc., 2001-08-14
"During manufacture of the xxxxx biobatch the blended granulation was screened and reblended for an additional xxxxx minutes, which is not done in the commercial batches. The biobatch was also blended for xxxxx minutes and the current process specifies a xxxxx minute blend. It is not known what effect, if any, the differences would have on the composition, dissolution, and bioequivalence of these tablets."

PDF file (366 KB)
Purepac Pharmaceutical Company, 2001-04-09
"Lot497F9, Expiry 5/2001, failed Level 3 dissolution testing at the four hour point, and was released prior to completion of the laboratory investigation. It was later determined that the lot was released by the QA Supervisor based on bulk reassay results rather than finished product results. This lot was also placed on stabili