Neurotech Pharmaceuticals, Inc. – FDA 483, Jul 26, 2024

The FDA issued a Form 483 to Neurotech Pharmaceuticals, Inc. following an inspection conducted from July 22-26, 2024, at their drug substance and drug product manufacturing facility in Cumberland, RI. The inspection revealed critical deficiencies in the company's quality system and manufacturing controls, particularly for their NT-501 combination product. Key observations included management's failure to ensure an adequate and effective quality system, specifically regarding the quality policy's implementation and the appointment of a management representative. Inadequate quality oversight was noted, with unapproved quality agreements for critical suppliers and operational deviations from written procedures during drug substance processing and testing. Furthermore, production and process control procedures were found to be insufficient, and personnel training was inadequate, leading to operators needing assistance with assigned tasks. The company also failed to open deviations in a timely manner, and batch record documentation practices were insufficient. Finally, the manual visual inspection program for the NT-501 combination product was deemed inadequate due to procedural deficiencies and non-adherence to established inspection methods. Neurotech Pharmaceuticals is required to address these observations with comprehensive corrective actions to ensure compliance with quality and manufacturing standards for product identity, strength, quality, and purity.