# Janssen Ortho LLC, Gurabo, PR – FDA Inspections

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

> Inspection records and compliance data for Janssen Ortho LLC in Gurabo, Puerto Rico. 7 FDA inspections on record, 4 Form 483s, last inspected June 05, 2026.

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## Details

- Name: Janssen Ortho LLC
- FEI Number: 3002942061
- Business Operations: FDF MANUFACTURE
- Address Line 1: State Road 933 Km 0.1,Mamey Ward
- City: Gurabo
- State: Puerto Rico
- Zip Code: 00778
- Country Name: United States
- Address: State Road 933 Km 0.1,Mamey Ward, Gurabo, Puerto Rico 00778, United States
- Country: United States

## Related Documents

- [483 - Janssen Ortho LLC - 2026-06-05](https://www.keypedia.com/records/483/janssen-ortho-llc/ce1f2696-c1c5-4af6-8fcd-2a4c219e57ca) — source: FDA, date: June 5, 2026
- [FDA Inspection 1320870 - Janssen Ortho LLC - 2026-06-05](https://www.keypedia.com/records/fda_inspections/janssen-ortho-llc/67acf1a5-b858-4c2c-bb88-e0ac0e3818da) — source: FDA, date: June 5, 2026
- [483 - Janssen Ortho LLC - 2023-03-28](https://www.keypedia.com/records/483/janssen-ortho-llc/4cad2a5e-77d8-4672-99e2-524ba5b40858) — source: FDA, date: March 28, 2023
- [FDA Inspection 1200973 - Janssen Ortho LLC - 2023-03-28](https://www.keypedia.com/records/fda_inspections/janssen-ortho-llc/54aa5390-c872-413c-bb87-2542b72ef9b4) — classification: Voluntary Action Indicated (VAI), source: FDA, date: March 28, 2023
- [483 - Janssen Ortho LLC - 2018-08-28](https://www.keypedia.com/records/483/janssen-ortho-llc/7d33606c-84b5-4040-ba37-a1042b2ddd77) — source: FDA, date: August 28, 2018
- [FDA Inspection 1063744 - Janssen Ortho LLC - 2018-08-28](https://www.keypedia.com/records/fda_inspections/janssen-ortho-llc/4c91b92d-4597-4c58-9e17-38de8ee2a589) — classification: Voluntary Action Indicated (VAI), source: FDA, date: August 28, 2018
- [483 - Janssen Ortho LLC - 2017-05-26](https://www.keypedia.com/records/483/janssen-ortho-llc/0bec2afd-b051-4eb4-9f4f-f3f7a67b01d4) — source: FDA, date: May 26, 2017
- [FDA Inspection 1012089 - Janssen Ortho LLC - 2017-05-26](https://www.keypedia.com/records/fda_inspections/janssen-ortho-llc/17770b44-9e8e-4aec-baff-f13a6ae5f3dd) — classification: Voluntary Action Indicated (VAI), source: FDA, date: May 26, 2017
- [483 - Janssen Ortho LLC - 2016-05-18](https://www.keypedia.com/records/483/janssen-ortho-llc/c55dee69-a80a-4c80-b7a1-659066e15196) — source: FDA, date: May 18, 2016
- [483 - Janssen Ortho LLC - 2016-02-22](https://www.keypedia.com/records/483/janssen-ortho-llc/fb129a2c-9d30-477a-b2cc-7094454a5404) — source: FDA, date: February 22, 2016
- [483 - Janssen Ortho LLC - 2015-05-29](https://www.keypedia.com/records/483/janssen-ortho-llc/bd2309b1-da7d-4d78-958e-2793e7e36fdd) — source: FDA, date: May 29, 2015
- [FDA Inspection 930456 - Janssen Ortho LLC - 2015-05-29](https://www.keypedia.com/records/fda_inspections/janssen-ortho-llc/ca7c6639-39bb-4542-b106-9817ad3e550b) — classification: Voluntary Action Indicated (VAI), source: FDA, date: May 29, 2015
- [483 - Janssen Ortho LLC - 2013-02-22](https://www.keypedia.com/records/483/janssen-ortho-llc/76b75231-a217-4952-91f1-3662e4ffad10) — source: FDA, date: February 22, 2013
- FDA Inspection 819622 - Janssen Ortho LLC - 2013-02-22 — classification: Voluntary Action Indicated (VAI), source: FDA, date: February 22, 2013
- FDA Inspection 819622 - Janssen Ortho LLC - 2013-02-22 — classification: Voluntary Action Indicated (VAI), source: FDA, date: February 22, 2013
- [483 - Janssen Ortho LLC - 2011-06-13](https://www.keypedia.com/records/483/janssen-ortho-llc/9f01de45-456f-4580-a094-c4044333d924) — source: FDA, date: June 13, 2011
- [FDA Inspection 729698 - Janssen Ortho LLC - 2011-06-13](https://www.keypedia.com/records/fda_inspections/janssen-ortho-llc/6f062533-f5c3-4051-b944-7f330e846b58) — classification: Voluntary Action Indicated (VAI), source: FDA, date: June 13, 2011
- [483 - Janssen Ortho LLC - 2009-06-08](https://www.keypedia.com/records/483/janssen-ortho-llc/2e5e88a1-b52a-4df6-985e-268fd2d791e7) — source: FDA, date: June 8, 2009

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## Related Officers

- [Program Director](https://www.keypedia.com/people/ramon-a-hernandez/12807db4-f78b-4579-b66c-bae9096ec2d4)
- [Lilia M Lugo](https://www.keypedia.com/people/lilia-m-lugo/bd409997-f589-4d2d-b7ba-4b52f222e43e)
- [Investigator ](https://www.keypedia.com/people/raquel-gonzalez-rivera/84cdd41f-b03c-4d13-a289-e2ebf4417c3c)
- [Angelica M. Hernandez](https://www.keypedia.com/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)