PDF file (282 KB)
Mayne Pharma Pty., Ltd., 2002-11-21
"The reproducibility of the method was not demonstrated. For example, only one result following a negative recovery was used to validate the method." "It clarified that the counts used to initially inoculate the test and control samples are quantified, but you don't explain how the procedure is done. It also states that an update to the validation requirement such that three validation tests will be performed in order to comply with the rewements of Validation from Pharmacopeial Articles"

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Earlham College, 2002-07-29
"No validation of the test method for analysis for the in-process materials and finished dosage forms supplied by the contracting manufacturer."
"No verification that the test method using HPLC for Folic Acid analysis, following changes made by the laboratory from the official USP compendium method, is suitable for conditions of use in the testing of the contracting manufacturer's in process and finished dosage forms."

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D.S.C. Products, Inc., 2002-07-09
"Data is not available to establish that the analytical methods used to assay finished products meet proper standards of accuracy and reliability as applied to the product tested."
"Failure to ensure that the cleaning methods used to clean equipment and utensils are adequate to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond established requirements, as required by 21 CFR 211.67."

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Eight In One Pet Products, Inc., 2002-06-14
"Failure to verify the suitability of all testing methods under actual conditions of use. [21 CFR 211.194]. There are no records of test method validation to assure accuracy and reliability. The adequacy of the contract testing laboratory has not been established, such a