# FDA 483 - Janssen Ortho LLC - June 08, 2009

Source: https://www.globalkeysolutions.net/records/483/janssen-ortho-llc/2e5e88a1-b52a-4df6-985e-268fd2d791e7

> FDA 483 for Janssen Ortho LLC on June 08, 2009. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Janssen Ortho LLC
- Inspection Date: 2009-06-08
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Janssen Ortho LLC in Gurabo, PR, from May 26 to June 8, 2009, revealed significant deficiencies in quality control unit procedures and manufacturing batch records. The firm failed to provide documented evidence for validation sample collection and lacked accurate documentation for in-process controls and manufacturing deviations for Carisbamate Tablets. These issues indicate a lack of adherence to established protocols and proper record-keeping practices.

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## Related Officers

- [José E. Meléndez](https://www.globalkeysolutions.net/people/jose-e-melendez/2fc712a0-968d-489c-af88-daf555b582b6)

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