FDA Form 483 Janssen, Raritan, NJ Oct 2024
Form 483 issued November 1, 2024 · Raritan, New Jersey
- Inspection
- Oct 28 – Nov 1, 2024
- Investigators
- Carl Perez· Kevin Matthews· Xiuju Lu
- Observations
- 2
- Pages
- 2
- FEI number
- 2211100
In short: On November 1, 2024, FDA issued a Form 483 with 2 observations to FDA Form 483 Janssen, Raritan, NJ Oct 2024 in Raritan, New Jersey (FEI 2211100) after an inspection that ran Oct 28 – Nov 1, 2024. The investigators were Carl Perez, Kevin Matthews and Xiuju Lu. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.67 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control and maintenance of…
- 02
Investigations (nonconformance reports) are not initiated in a timely manner after detection of a deviation according…
This inspection in context
Carl Perez
7 documents · 2022–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
The firmFDA Form 483 Janssen, Raritan, NJ Oct 2024 history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FDA Form 483 Janssen, Raritan, NJ Oct 2024?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected FDA Form 483 Janssen, Raritan, NJ Oct 2024?
Carl Perez, Kevin Matthews and Xiuju Lu are named on this Form 483, for the inspection of Oct 28 – Nov 1, 2024. Each investigator has a profile showing what they cite most.
When was FDA Form 483 Janssen, Raritan, NJ Oct 2024 inspected by FDA?
The inspection ran Oct 28 – Nov 1, 2024, and the Form 483 is dated November 1, 2024.
How do I get the full Form 483 for FDA Form 483 Janssen, Raritan, NJ Oct 2024?
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.