# FDA 483 - Janssen Biotech, Inc. - March 05, 2018

Source: https://www.keypedia.com/records/483/janssen-biotech-inc/7bb1eae4-93cc-4e04-a24d-a92ba5419340

> FDA 483 for Janssen Biotech, Inc. on March 05, 2018. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Janssen Biotech, Inc.
- Inspection Date: 2018-03-05
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Janssen Biotech, Inc.'s Malvern, PA facility, conducted from February 21 to March 5, 2018, revealed significant issues in their quality control and investigation procedures. The Food and Drug Administration observed that written records of investigations into batch failures and out-of-specification components were incomplete. Specifically, several batches of Bovine APO Transferrin were released and utilized in API production, despite exceeding Ethylenediaminetetraacetic Acid (EDTA) action limits, without thorough lab event investigations. The media lots containing these non-compliant components were also not tested for EDTA. Additionally, an investigation into a decreased Process Capability for API Pre-formulated Bulk (PFB) Bioactivity Assay was deemed incomplete due to the absence of a review and assessment of stability data. These observations highlight the necessity for Janssen Biotech, Inc. to enhance their investigative processes for product and component deviations to ensure comprehensive root cause analysis and maintain consistent product quality and regulatory compliance. The company is expected to implement robust corrective actions to address these findings.

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## Related Officers

- [General Manager of Operations](https://www.keypedia.com/people/christopher-j-ewer/7865790c-c711-4253-83b1-492f20d6e831)
- [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