# Janssen Ortho LLC – FDA 483, Feb 22, 2016

Source: https://www.keypedia.com/records/483/janssen-ortho-llc/fb129a2c-9d30-477a-b2cc-7094454a5404

> FDA 483 for Janssen Ortho LLC on February 22, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Janssen Ortho LLC
- Inspection Date: 2016-02-22
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Janssen Ortho LLC in Gurabo, PR, received a Form 483 with three observations related to manufacturing drug products. The inspection revealed deficiencies in the routine maintenance of automated control systems, inadequate computer system controls for record changes, and a lack of proper records and procedures for equipment maintenance and cleaning. These issues indicate a moderate level of concern regarding quality system oversight and data integrity.

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## Related Officers

- [Arwa ElHagrasy, Staff Fellow OPF](https://www.keypedia.com/people/arwa-elhagrasy-staff-fellow-opf/0d3f4959-e102-415f-96d5-ed98eebbb81a)
- [Sharmista Chatterjee, Acting DD, OPF](https://www.keypedia.com/people/sharmista-chatterjee-acting-dd-opf/e471a7cb-94d3-4f93-8cf0-eb181b62f43f)
- [Christina Oprica-Daniel, CSO OPF](https://www.keypedia.com/people/christina-oprica-daniel-cso-opf/3e5b3d72-feff-4aa9-813f-166b8c208e73)
- [Investigator](https://www.keypedia.com/people/noreen-muniz/0bb20d12-62ad-42aa-8b0a-c44b339d413f)

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