# FDA 483 - Janssen Pharmaceuticals, Inc. - January 24, 2025

Source: https://www.globalkeysolutions.net/records/483/janssen-pharmaceuticals-inc/b93b2d5e-234b-40ad-8fb0-4a75c2014dc0

> FDA 483 for Janssen Pharmaceuticals, Inc. on January 24, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Janssen Pharmaceuticals, Inc.
- Inspection Date: 2025-01-24
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Janssen Pharmaceuticals Inc. in Athens, GA, an Active Pharmaceutical Ingredient (API) manufacturer, was cited for an inadequate raw material receipt sampling method during an FDA inspection. The firm failed to ensure representative sampling of drummed raw materials, lacked documented evidence for sampled containers, and had a sampling procedure that did not specify amounts or locations for sampling. This deficiency affected the manufacture of several API lots, including Apalutamide and Esketamine HCL.

## Related Officers

- [Alan A. Rivera](https://www.globalkeysolutions.net/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)
- [Samantha E. Cleek](https://www.globalkeysolutions.net/people/samantha-e-cleek/7305f28f-9c92-427d-86ec-42c0bb6bf3ce)

Company: https://www.globalkeysolutions.net/companies/janssen-pharmaceuticals-inc/85608d29-c3f2-4614-a3c7-552a111ccfaa

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7