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 (282 KB)
Mayne Pharma Pty., Ltd., 2002-11-21
"inadequate validation of the sterilization process in no microbiological qualification or determination of the resistance of the biological indicator challenge system was performed"

PDF file (334 KB)
D.S.C. Products, Inc., 2002-07-09
"Written procedures do not define how process validation will be conducted or documented."
"Failure to establish and follow validated sampling and testing procedures of in-process materials and drug products to assure batch uniformity and integrity of drug products, as required by 21 CFR 211.110."

PDF file (392 KB)
St. Gobain Ceramiques Avancees Desmarquest, 2002-04-26
"Failure to adequately validate the tunnel furnace process with a high degree of assurance and approve according to established procedures, as required by 21 CFR 820.75(a). For example, your xxx furnace validation summary report and additional process validation information do not document that the xxx process parameters are consistently controlled and result in the desired product specifications. The process validation protocol, contained in your March 11, 2002, submission does not describe how the process parameters and product specifications are measured or tested."
"the process validation report does not document that the xxx furnace process itself results in a consistent, predictable outco