Dearth of Quality Testing Results in 483 for API Maker
The FDA slapped a Chicago API manufacturer with a Form 483 for a lack of identification testing and blending batches.
During a June to August inspection of Vantage Oleochemicals’ Chicago facility, agency investigators discovered that the company did not test each batch of glycerine to determine conformance to the full U.S. Pharmacopeia (USP) monograph.
Instead of testing each batch, the company blended numerous batches together and tested those for conformance with the USP monograph.
“As an example, the firm blended six lot numbers … into one composite sample,” reads the form with three observations.
The company also doesn’t use the current USP monograph test method for assay determination for glycerine. It hasn’t validated the method that it does use to determine if it is equivalent or better than the USP method, the form reads.