FDA 483 - Rhone-Poulenc Rorer Puerto Rico, Inc. - September 23, 1999

This FDA Form 483 report for RHONE-POULENC RORER P.R. INC. in Manati, Puerto Rico, details significant deficiencies in quality control, laboratory operations, and timely regulatory reporting. The inspection revealed issues across multiple drug products, including failures in stability testing, supplier qualification, and computer system validation, indicating a systemic lack of adherence to good manufacturing practices and regulatory requirements.