# FDA 483 - Janssen Ortho LLC - May 29, 2015

Source: https://www.keypedia.com/records/483/janssen-ortho-llc/bd2309b1-da7d-4d78-958e-2793e7e36fdd

> FDA 483 for Janssen Ortho LLC on May 29, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Janssen Ortho LLC
- Inspection Date: 2015-05-29
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Janssen Ortho L.L.C. in Gurabo, PR, a drug manufacturer, was inspected and cited for significant deficiencies in its quality control and sampling procedures. Observations included inadequate documentation and in-process controls for packaging, leading to inaccurate product counts, and non-representative sampling plans for both drug products and incoming raw materials. These issues indicate a systemic failure to ensure product quality and compliance with manufacturing specifications.

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## Related Officers

- [Vilmary Negron Rodriguez, Investigator](https://www.keypedia.com/people/vilmary-negron-rodriguez-investigator/09e5963b-2828-4ddd-8147-74238e85a2ec)
- [Investigator](https://www.keypedia.com/people/binh-t-nguyen/14ca5620-1f92-4f5d-8663-3b63814aca26)
- [Dennis Cantellops Paite](https://www.keypedia.com/people/dennis-cantellops-paite/3336bbb8-8520-4a8a-9085-76e7a55ca773)
- [Retired](https://www.keypedia.com/people/ariel-cruz-figueroa/c6ade050-dbe1-4aa3-b88f-980db51b88b0)
- [Laurimer Kuulan-Torres](https://www.keypedia.com/people/laurimer-kuulan-torres/c9c7d245-50a9-427b-962f-a50f00d7ada7)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6