# FDA 483 - Neurotech Pharmaceuticals, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/neurotech-pharmaceuticals-inc/ee97bf90-2ae1-41fb-b77b-537e65b91994

> 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: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Carolina Panico, Biologist](https://www.keypedia.com/people/carolina-panico-biologist/5e8dc385-ce21-4389-b296-1db3acf2fbec)
- [Miriam Ngondi, Lead Inspector, CSO](https://www.keypedia.com/people/miriam-ngondi-lead-inspector-cso/846cc7f5-18c2-4e0e-928b-7a0b7fdfa432)
- [Kyung Sung, Supervisory Biologist](https://www.keypedia.com/people/kyung-sung-supervisory-biologist/9ad2242d-07a8-46c7-95a4-c5b9cab57d56)
- [Kiyan Etchist, Supervisory Biologist](https://www.keypedia.com/people/kiyan-etchist-supervisory-biologist/dcb4f4e8-c2d9-466d-9077-29b6a6bf08e6)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd