# FDA 483 - Niagara Pharmaceuticals Inc - April 25, 2022

Source: https://www.globalkeysolutions.net/records/483/niagara-pharmaceuticals-inc/c0f994c8-b70b-45a1-aaa0-ee60bd718b76

> FDA 483 for Niagara Pharmaceuticals Inc on April 25, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Niagara Pharmaceuticals Inc
- Inspection Date: 2022-04-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Niagara Pharmaceuticals Inc, a manufacturer in Dundas, was inspected by the FDA, resulting in four observations. The inspection revealed deficiencies in quality control unit procedures, vendor qualification, sampling criteria for packaging materials, manufacturing process validation, and the determination of actual and theoretical yields. These issues indicate a need for improved adherence to Good Manufacturing Practices.

## Related Officers

- [Consumer Safety Officer (Drug Specialist)](https://www.globalkeysolutions.net/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)

Company: https://www.globalkeysolutions.net/companies/niagara-pharmaceuticals-inc/86d1fc76-da98-4df3-bf23-bed8075fdd53

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1