# FDA 483 - RISING PHARMACEUTICALS INC - January 28, 2019

Source: https://www.keypedia.com/records/483/rising-pharmaceuticals-inc/1c44775e-ded9-4d72-afed-d114de03b523

> FDA 483 for RISING PHARMACEUTICALS INC on January 28, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RISING PHARMACEUTICALS INC
- Inspection Date: 2019-01-28
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Rising Pharmaceuticals Inc. in Saddle Brook, NJ, revealed a significant issue regarding the timely submission of periodic adverse drug experience reports. The firm failed to submit required quarterly reports for cevimeline hydrochloride (ANDA# 203775) for multiple reporting periods in 2016 and 2017. This indicates a non-compliance with drug safety reporting requirements.

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)

Company: https://www.keypedia.com/companies/rising-pharmaceuticals-inc/b1ade06f-36e2-45cd-bae9-a6720cf39f86

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248