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

Source: https://www.keypedia.com/records/483/janssen-pharmaceuticals-inc/af0cd37e-676f-4678-8ff8-a75e9f479215

> 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: During an inspection conducted from January 22-24, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Janssen Pharmaceuticals Inc. in Athens, GA, an Active Pharmaceutical Ingredient (API) manufacturer. The primary observation concerned the company's raw material receipt sampling method, which was deemed inadequate and lacking scientifically sound sampling plans. Specifically, the FDA noted that Janssen Pharmaceuticals Inc. failed to ensure representative sampling for drummed raw materials. An instance was cited where a raw material used for Apalutamide API lacked a sampling label and documented evidence of sampling. Furthermore, the firm’s "Sampling Procedure" (TV-SOP-23403) did not specify the required sample quantity or collection location from each container, with operators visually estimating amounts. This insufficient sampling method has been applied to numerous batches of Apalutamide, Esketamine HCL, Methylphenidate HCL, and Topiramate API manufactured since April 2024. This inspectional observation falls under the regulatory framework of Section 704(b) of the Federal Food, Drug and Cosmetic Act. Janssen Pharmaceuticals Inc. is required to address these findings, typically by submitting a written response detailing their corrective actions and preventive measures to ensure the quality and purity of their raw materials and finished products.

## Related Documents

- [483 - 2025-01-24](https://www.keypedia.com/records/483/janssen-pharmaceuticals-inc/b93b2d5e-234b-40ad-8fb0-4a75c2014dc0)

## Related Officers

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

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

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