FDA 483 - Neurotech Pharmaceuticals, Inc.

An FDA inspection of Neurotech Pharmaceuticals, Inc. in Cumberland, RI, a manufacturer of drug substance and drug product, revealed significant deficiencies in its quality system and manufacturing controls. The firm failed to establish an adequate quality system, ensure proper quality oversight for its NT-501 combination product, and maintain sufficient procedures, training, and documentation practices. Additionally, the manual visual inspection program for the NT-501 product was found to be inadequate.