# FDA 483 - Janssen Cilag Manufacturing LLC - February 11, 2026

Source: https://www.keypedia.com/records/483/janssen-cilag-manufacturing-llc/fd42b175-7333-4ade-9304-e1886820ba89

> FDA 483 for Janssen Cilag Manufacturing LLC on February 11, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Janssen Cilag Manufacturing LLC
- Inspection Date: 2026-02-11
- Product Type: drugs
- Office Name: San Juan District Office
- Summary: Janssen Cilag Manufacturing LLC in Gurabo, PR, received a Form 483 with two observations related to inadequate quality control. The firm failed to establish scientifically sound sampling plans and test procedures for drug product release and did not thoroughly investigate unexplained product discrepancies, including a previously observed deficiency. These issues indicate significant concerns with the firm's laboratory controls and quality system.

## Related Documents

- [483 - 2021-11-23](https://www.keypedia.com/records/483/janssen-cilag-manufacturing-llc/e0b0a5c6-5467-48bd-aae5-b206e45b4d41)

## Related Officers

- [Yoriann M. Cabrera Bartolomei](https://www.keypedia.com/people/yoriann-m-cabrera-bartolomei/3f827fbc-dcd1-4698-9bae-e0e93b900d08)
- [investigator](https://www.keypedia.com/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)
- [Investigator ](https://www.keypedia.com/people/raquel-gonzalez-rivera/84cdd41f-b03c-4d13-a289-e2ebf4417c3c)

Company: https://www.keypedia.com/companies/janssen-cilag-manufacturing-llc/7d4fb569-3ecd-4de2-8235-c44b7292990f

Office: https://www.keypedia.com/offices/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8