Janssen Vaccines Corporation
Form 483 issued November 19, 2024 · Incheon, South Korea
- Inspection
- Nov 11 – Nov 19, 2024
- Investigator
- Rajiv R. Srivastava
- Observations
- 5
- Pages
- 7
- FEI number
- 3012637764
In short: On November 19, 2024, FDA issued a Form 483 with 5 observations to Janssen Vaccines Corporation in Incheon, South Korea (FEI 3012637764) after an inspection that ran Nov 11 – Nov 19, 2024. The investigator was Rajiv R. Srivastava. Most observations concern facilities & equipment and biologics CGMP; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Responsibilities and procedures for quality units ai·e not in writing and/or followed to ensure the FARS…
- 02
Procedure designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Aseptic processing areas ai·e deficient regai·ding systems for maintaining any equipment used to…
- 04
Aseptic processing areas ai·e deficient regai·ding the system for cleaning an d disinfecting the room an…
This inspection in context
Rajiv R. Srivastava
30 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmJanssen Vaccines Corporation history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Janssen Vaccines Corporation?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, biologics CGMP and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Janssen Vaccines Corporation?
Rajiv R. Srivastava is named on this Form 483, for the inspection of Nov 11 – Nov 19, 2024. Each investigator has a profile showing what they cite most.
When was Janssen Vaccines Corporation inspected by FDA?
The inspection ran Nov 11 – Nov 19, 2024, and the Form 483 is dated November 19, 2024.
How do I get the full Form 483 for Janssen Vaccines Corporation?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.