# FDA 483 - Janssen Ortho LLC - June 13, 2011

Source: https://www.globalkeysolutions.net/records/483/janssen-ortho-llc/9f01de45-456f-4580-a094-c4044333d924

> FDA 483 for Janssen Ortho LLC on June 13, 2011. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Janssen Ortho LLC
- Inspection Date: 2011-06-13
- 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 cited for deficiencies in its quality system. The firm failed to adequately investigate a product recall for Topomax due to TBA contamination, not extending the assessment to all potentially affected batches. Additionally, laboratory controls for evaluating drug products for contaminants were found to be insufficient.

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## Related Officers

- [Program Director](https://www.globalkeysolutions.net/people/ramon-a-hernandez/12807db4-f78b-4579-b66c-bae9096ec2d4)

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