FDA 483 - Fenwal International, Inc. - September 26, 2019

Fenwal International, Inc. in Maricao, PR, was inspected and received a Form 483 with six observations related to significant quality system deficiencies. The inspection revealed issues with laboratory data integrity, inadequate microbiological testing of components, and a lack of proper procedures to prevent contamination of sterile drug products. Additionally, the firm failed to maintain appropriate equipment design, follow complaint investigation procedures, and correctly identify in-process materials.