# Raritan Pharmaceuticals, Inc. – FDA 483, Apr 2, 2025

Source: https://www.keypedia.com/records/483/raritan-pharmaceuticals-inc/40152ae1-9027-4ee5-b69c-f866741ada0e

> FDA 483 for Raritan Pharmaceuticals, Inc. on April 02, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Raritan Pharmaceuticals, Inc.
- Inspection Date: 2025-04-02
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Raritan Pharmaceuticals, Inc. in East Brunswick, NJ, was cited for significant deficiencies in their manufacturing and quality control processes for OTC drug products. The inspection revealed a lack of impurity and microbial testing for released products, inadequate sampling of high-risk components, and insufficient cleaning and process validation procedures. Additionally, the firm's training program for analysts was found to be ineffective, contributing to a high number of unresolved Out-of-Specification investigations.

## Related Officers

- [Alisha B. Patel](https://www.keypedia.com/people/alisha-b-patel/3c106dac-0e0d-41f2-9f7a-69982d4e6579)
- [Investigator](https://www.keypedia.com/people/janet-a-rajan/95741927-9a4d-422b-bd51-01783d962cbe)

Company: https://www.keypedia.com/companies/raritan-pharmaceuticals-inc/31d76ce5-e5b2-4f61-b7b5-daa1a81f7cf0

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