# Neurotech Pharmaceuticals, Inc. – FDA 483

Source: https://www.keypedia.com/records/483/neurotech-pharmaceuticals-inc/f3b7e59a-93e3-41d4-b381-42f140726764

> FDA 483 for Neurotech Pharmaceuticals, Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neurotech Pharmaceuticals, Inc.
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: 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.

## Related Documents

- [483 - 2024-07-26](https://www.keypedia.com/records/483/neurotech-pharmaceuticals-inc/a9460b8e-e109-44b7-94e1-4be25825e949) — date: July 26, 2024

## Related Officers

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Company: https://www.keypedia.com/companies/neurotech-pharmaceuticals-inc/54a73df4-05e1-44cd-970b-9655a03d1d53

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4