FDA 483 - Rhone-Poulenc Rorer Puerto Rico, Inc. - February 10, 2000

An FDA inspection of Rhone-Poulenc Rorer Puerto Rico, Inc. in Manati, Puerto Rico, revealed significant deficiencies across multiple areas. The firm was cited for delayed field alerts and stability testing for Klaron Lotion, unvalidated computer software, and widespread issues with purified water quality control, including failure to perform required TOC analysis and implement corrective actions. Additionally, the firm failed to generate a chemical component release form and conducted an inadequate method transfer study.