Janssen Vaccines Corporation
Form 483 issued March 10, 2022 · Incheon, South Korea
- Inspection
- Mar 2 – Mar 10, 2022
- Investigator
- Melissa Ray
- Observations
- 8
- Pages
- 3
- FEI number
- 3012637764
In short: On March 10, 2022, FDA issued a Form 483 with 8 observations to Janssen Vaccines Corporation in Incheon, Yeonsu-gu (FEI 3012637764) after an inspection that ran Mar 2 – Mar 10, 2022. The investigator was Melissa Ray. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
5 of 8 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (5×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Visual inspection program for…
- 03
Validation for equipment used in the manufacturing of…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Melissa Ray
3 documents · 2022–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Lithuania.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Janssen Vaccines Corporation?
FDA listed 8 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Janssen Vaccines Corporation?
Melissa Ray is named on this Form 483, for the inspection of Mar 2 – Mar 10, 2022. Each investigator has a profile showing what they cite most.
When was Janssen Vaccines Corporation inspected by FDA?
The inspection ran Mar 2 – Mar 10, 2022, and the Form 483 is dated March 10, 2022.
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.