Company: Unico Holdings Inc.
Product: Over-the-counter drug products
Date: 10/18/02

In answer to observations made about not performing specific gravity testing as required by the covering monograph, your response states your belief that under certain circumstances not every analytical procedure listed in an article’s monograph needs to be performed, but offers no documentation or historical data to support your belief. Further, our investigators found that the computer program used by your firm to calculate the percentage of theoretical yield bases this calculation on the specific gravity of the batch, a test which, by your own admission, is not performed. Please submit any documentation you may have supporting the calculations of this computer program.

FDA District: Florida