FDA 483 - Neurotech Pharmaceuticals, Inc.

Neurotech Pharmaceuticals, Inc. in Cumberland, RI, a drug substance and drug product manufacturer, was cited with three observations during an FDA inspection. The findings indicate significant deficiencies in the firm's quality system, including inadequate management responsibility, insufficient quality oversight for its NT-501 combination product, and an inadequate manual visual inspection program. These issues collectively suggest a lack of robust controls over manufacturing processes and product quality.