# FDA 483 - Janssen Biotech, Inc. - May 18, 2026

Source: https://www.keypedia.com/records/483/janssen-biotech-inc/49d46fef-c43c-4edf-92a6-85e4dd41c6cb

> FDA 483 for Janssen Biotech, Inc. on May 18, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Janssen Biotech, Inc.
- Inspection Date: 2026-05-18
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: During an inspection, Janssen Biotech, Inc. in Malvern, PA was cited for incomplete written records of investigations. Specifically, the firm failed to adequately investigate out-of-specification batches of Bovine APO Transferrin and a decrease in process capability for API Pre-formulated Bulk Bioactivity Assay. These issues indicate deficiencies in the firm's quality control unit and investigation procedures.

## Related Documents

- [483 - 2018-03-05](https://www.keypedia.com/records/483/janssen-biotech-inc/7bb1eae4-93cc-4e04-a24d-a92ba5419340)
- [483 - 2025-07-29](https://www.keypedia.com/records/483/janssen-biotech-inc/91999c27-fff3-4a2e-af28-81a6a8053369)

## Related Officers

- [Investigator](https://www.keypedia.com/people/anita-r-michael/b7699b1a-4157-477e-8226-2cfc906fc61d)

Company: https://www.keypedia.com/companies/janssen-biotech-inc/5374365d-a0df-4a87-ad3d-2714628d3e57

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8