# FDA 483 - Janssen Ortho LLC - May 18, 2016

Source: https://www.globalkeysolutions.net/records/483/janssen-ortho-llc/c55dee69-a80a-4c80-b7a1-659066e15196

> FDA 483 for Janssen Ortho LLC on May 18, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Janssen Ortho LLC
- Inspection Date: 2016-05-18
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Janssen Ortho L.L.C. in Gurabo, PR, was issued a Form 483 following an inspection from May 11-18, 2016, for deficiencies in its quality control unit. Operators incorrectly calculated average weights in master batch records for Canagliflozin/Metformin drug products. This significant error went undetected by quality assurance during their audits, indicating a failure in oversight and record review.

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## Related Officers

- [Laurimer Kuulan-Torres](https://www.globalkeysolutions.net/people/laurimer-kuulan-torres/c9c7d245-50a9-427b-962f-a50f00d7ada7)

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

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