FDA 483 - Professional Disposables International, Inc. - December 18, 2006

On December 12-18, 2006, an FDA inspection was conducted at Nice-Pak Products, Inc., a manufacturer located at 2 Nice Pak Park, Orangeburg, NY 10962-1317. The inspection identified one observation.

The firm failed to maintain records for annual review to evaluate the quality standards of each drug product and determine the need for changes in specifications or manufacturing/control procedures. Specifically, a change control form was not completed for a planned deviation in the manufacturing process for drug product (b)(4). The current commercial manufacturing process for this product does not include a filtration step that was submitted in the application and approved in June 2005. Since the approval, approximately (b)(4) batches of (b)(4) have been manufactured without this filtration step. This indicates a lack of proper documentation and control over manufacturing process deviations.