# Janssen Biotech, Inc., Malvern, PA – FDA Inspections

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

> Inspection records and compliance data for Janssen Biotech, Inc. in Malvern, Pennsylvania. 15 FDA inspections on record, 3 Form 483s, last inspected July 29, 2025.

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## Details

- Name: Janssen Biotech, Inc.
- FEI Number: 3001610451
- Address Line 1: 200 Great Valley Pkwy
- City: Malvern
- State: Pennsylvania
- Zip Code: 19355
- Country Name: United States
- Address: 200 Great Valley Pkwy, Malvern, Pennsylvania 19355, United States
- Country: United States

## Related Documents

- [483 - Janssen Biotech, Inc. - 2025-07-29](https://www.keypedia.com/records/483/janssen-biotech-inc/91999c27-fff3-4a2e-af28-81a6a8053369) — source: FDA, date: July 29, 2025
- [FDA Inspection 1276933 - Janssen Biotech, Inc. - 2025-07-29](https://www.keypedia.com/records/fda_inspections/janssen-biotech-inc/0ecc31ca-e799-4909-bfc9-dcdfa484fbf5) — source: FDA, date: July 29, 2025
- FDA Inspection 1276933 - Janssen Biotech, Inc. - 2025-07-29 — classification: Voluntary Action Indicated (VAI), source: FDA, date: July 29, 2025
- FDA Inspection 1265723 - Janssen Biotech, Inc. - 2025-03-10 — source: FDA, date: March 10, 2025
- FDA Inspection 1265723 - Janssen Biotech, Inc. - 2025-03-10 — classification: No Action Indicated (NAI), source: FDA, date: March 10, 2025
- [EIR - Janssen Biotech, Inc. - 2018-11-30](https://www.keypedia.com/records/eir/janssen-biotech-inc/bfbfb079-348c-422b-b82a-739f6507036f) — source: FDA, date: November 30, 2018
- FDA Inspection 1077487 - Janssen Biotech, Inc. - 2018-11-30 — classification: No Action Indicated (NAI), source: FDA, date: November 30, 2018
- [EIR - Janssen Biotech, Inc. - 2018-03-05](https://www.keypedia.com/records/eir/janssen-biotech-inc/f1208d95-d1d1-4c0a-926b-52d5130846e7) — source: FDA, date: March 5, 2018
- [483 - Janssen Biotech, Inc. - 2018-03-05](https://www.keypedia.com/records/483/janssen-biotech-inc/7bb1eae4-93cc-4e04-a24d-a92ba5419340) — source: FDA, date: March 5, 2018
- [FDA Inspection 1046499 - Janssen Biotech, Inc. - 2018-03-05](https://www.keypedia.com/records/fda_inspections/janssen-biotech-inc/4135886d-b271-492a-8b05-81d78eba721b) — classification: Voluntary Action Indicated (VAI), source: FDA, date: March 5, 2018
- [FDA Inspection 1031776 - Janssen Biotech, Inc. - 2017-11-21](https://www.keypedia.com/records/fda_inspections/janssen-biotech-inc/2f697eb7-fa9a-4da8-b845-2d83b13b09f0) — classification: Voluntary Action Indicated (VAI), source: FDA, date: November 21, 2017
- FDA Inspection 1027122 - Janssen Biotech, Inc. - 2017-09-22 — source: FDA, date: September 22, 2017
- [483 - Janssen Biotech, Inc. - 2017-05-18](https://www.keypedia.com/records/483/janssen-biotech-inc/49d46fef-c43c-4edf-92a6-85e4dd41c6cb) — source: FDA, date: May 18, 2017
- [FDA Inspection 1007329 - Janssen Biotech, Inc. - 2017-02-27](https://www.keypedia.com/records/fda_inspections/janssen-biotech-inc/351b5c60-a476-40a2-a8d9-bd8135ee2f6c) — classification: No Action Indicated (NAI), source: FDA, date: February 27, 2017
- FDA Inspection 939172 - Janssen Biotech, Inc. - 2015-08-19 — classification: No Action Indicated (NAI), source: FDA, date: August 19, 2015

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## Related Officers

- [FDA_PERSONNEL](https://www.keypedia.com/people/greg-littrell/079538e8-a1f5-4079-8dfb-71c1d4db225b)
- [Jason W. Ratcliffe](https://www.keypedia.com/people/jason-w-ratcliffe/135daa55-b170-48b2-a883-0afcadf2d450)
- [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)