# FDA 483 - Janssen Ortho LLC - May 26, 2017

Source: https://www.keypedia.com/records/483/janssen-ortho-llc/0bec2afd-b051-4eb4-9f4f-f3f7a67b01d4

> FDA 483 for Janssen Ortho LLC on May 26, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Janssen Ortho LLC
- Inspection Date: 2017-05-26
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: The FDA inspection of Janssen Ortho L.L.C. in Gurabo, PR, revealed significant deficiencies across multiple systems, including quality, laboratory, facilities, equipment, and production. Key issues involved inadequate investigations into product discrepancies, deficient complaint handling, poor data integrity practices, and failures in equipment calibration and cleaning procedures. These findings collectively indicate a systemic lack of adherence to cGMP requirements, posing a moderate risk to product quality and patient safety.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/noreen-muniz/0bb20d12-62ad-42aa-8b0a-c44b339d413f)
- [Jose A Moreno](https://www.keypedia.com/people/jose-a-moreno/e2e9e306-e776-4a58-a5d5-4dc2814bc74b)
- [Jose R. Lopez](https://www.keypedia.com/people/jose-r-lopez/f4e8e5fa-4765-4d8b-828d-32c202f8dadc)

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