Janssen Vaccines Corporation
FDA inspection history in Incheon, South Korea, 2022 to 2025
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2022: one Form 483; 2024: one Form 483; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–25Two Form 483s and one warning letter, at Incheon, South Korea.
- 2022The longest 483 on file: 8 observations over 3 pages at Incheon, South Korea.
Cited most
Across all Janssen Vaccines observations on file
- 21 CFR 211.113Control of microbiological contamination6
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Janssen Vaccines file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Incheon, South Korea
Two Form 483s · 2022 to 2024 · 13 observations
Latest: Form 483, Nov 19, 2024 →
Also: one document not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-07-18 | Warning letter Warning letter | — | — | $99 |
| 2024-11-19 | 483 Form 483 | Incheon, South Korea | 5 | $99 |
| 2022-03-10 | 483 Form 483 | Incheon, South Korea | 8 | $99 |
Investigators on these documents
FEI number 3012637764 · most recent document Jul 18, 2025
About Janssen Vaccines Corporation
How many FDA Form 483s has Janssen Vaccines Corporation received?
FDA Intel has 2 Form 483s on file for Janssen Vaccines Corporation; the most recent is dated Nov 19, 2024.
When was Janssen Vaccines Corporation last inspected by FDA?
The most recent FDA inspection document on file for Janssen Vaccines Corporation is a Form 483 dated Nov 19, 2024, for the site in Incheon, South Korea.
What did FDA cite at Janssen Vaccines Corporation?
The regulations cited most in the observations on file for Janssen Vaccines Corporation are 21 CFR 211.113 (Control of microbiological contamination), 6 times; 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.160 (General requirements), 1 time.
Has Janssen Vaccines Corporation received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Janssen Vaccines Corporation; the most recent is dated Jul 18, 2025.