# Janssen Ortho LLC – FDA 483, Jun 5, 2026

Source: https://www.keypedia.com/records/483/janssen-ortho-llc/ce1f2696-c1c5-4af6-8fcd-2a4c219e57ca

> FDA 483 for Janssen Ortho LLC on June 05, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Janssen Ortho LLC
- Inspection Date: 2026-06-05
- Product Type: drugs
- Office Name: San Juan District Office
- Summary: Janssen Ortho LLC in Gurabo, PR, a non-sterile drug manufacturer, received a Form 483 with six observations primarily concerning quality control and production issues. Key deficiencies include inadequate nitrosamine risk assessments, insufficient cleaning validation for nitrosamine precursors, and a lack of ongoing nitrosamine testing for US-marketed products. Additionally, the firm failed to address recurring out-of-trend dissolution results, lacked controls against unauthorized record reproduction, and had incomplete laboratory record reviews.

## Related Documents

- [483 - 2023-03-28](https://www.keypedia.com/records/483/janssen-ortho-llc/4cad2a5e-77d8-4672-99e2-524ba5b40858) — date: March 28, 2023
- [483 - 2018-08-28](https://www.keypedia.com/records/483/janssen-ortho-llc/7d33606c-84b5-4040-ba37-a1042b2ddd77) — date: August 28, 2018
- [483 - 2017-05-26](https://www.keypedia.com/records/483/janssen-ortho-llc/0bec2afd-b051-4eb4-9f4f-f3f7a67b01d4) — date: May 26, 2017
- [483 - 2016-05-18](https://www.keypedia.com/records/483/janssen-ortho-llc/c55dee69-a80a-4c80-b7a1-659066e15196) — date: May 18, 2016
- [483 - 2016-02-22](https://www.keypedia.com/records/483/janssen-ortho-llc/fb129a2c-9d30-477a-b2cc-7094454a5404) — date: February 22, 2016

## Related Officers

- [Yoriann M. Cabrera Bartolomei](https://www.keypedia.com/people/yoriann-m-cabrera-bartolomei/3f827fbc-dcd1-4698-9bae-e0e93b900d08)
- [Elizabeth Rosa-Mercado](https://www.keypedia.com/people/elizabeth-rosa-mercado/612f737a-8496-4ec4-a885-d1da4a5611d3)
- [Investigator ](https://www.keypedia.com/people/raquel-gonzalez-rivera/84cdd41f-b03c-4d13-a289-e2ebf4417c3c)
- [Chemist/Biologist](https://www.keypedia.com/people/raquel-gonzalez-rivera/1776a126-e033-4e4c-a807-04955cc6a7f6)

Company: https://www.keypedia.com/companies/janssen-ortho-llc/d7bbb024-09b4-42ae-bbc5-fad0986f12c6

Office: https://www.keypedia.com/offices/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8