Where are you now? Intelligence Services > OOS > Related Warning Letters
OOS (Out-of-Specifications) Related Warning Letters
These files are in Adobe PDF format.
Click on the "Get Acrobat Reader" icon on the left of the page to
download a free copy of the Acrobat Reader.
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."
Eight In One Pet Products, Inc., 2002-06-14
"Failure to conduct a thorough investigation of unexplained discrepancies or the failure of a batch or any of its components to meet any of its specifications. [21 CFR 211.192]. There is no written investigation of piperazine citrate syrup, batch # 0421054 failure to meet assay specifications. The investigation of piperazine citrate raw material lot 20268 out of specification test results included retesting of new samples which was not thoroughly justified."
Vintage Pharmaceuticals, Inc., 2002-05-20
"We also have concerns that out of specification (00S) investigations of
Q Bid LA lots, manufactured in the time frame between the 2 sets of validation lots, are not discussed in either validation report, thus providing insufficient assurance that the manufacturing process for Q Bid LA is validated, as required by 21 C.F.R. 211.100(a), 211.110(a), and 211.110(b)."
West Agro, Inc., 2002-03-28
"There are no Standard Operating Procedures for the inspection of Out of Specification (00S) results [21 CFR 211.192]."
GOJO Indus | 
PDF file (240 KB)