FDA Form 483 Janssen, Raritan, NJ Oct 2024
Form 483 issued December 14, 2023 · Raritan, New Jersey
- Inspection
- Dec 5 – Dec 14, 2023
- Investigators
- Laurel A. Beer· Thai D. Truong
- Observations
- 4
- Pages
- 4
- FEI number
- 2211100
In short: On December 14, 2023, FDA issued a Form 483 with 4 observations to FDA Form 483 Janssen, Raritan, NJ Oct 2024 in Raritan, New Jersey (FEI 2211100) after an inspection that ran Dec 5 – Dec 14, 2023. The investigators were Laurel A. Beer and Thai D. Truong. Most observations concern laboratory controls and biologics CGMP.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to…
- 02
Failure to submit a…
- 03
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the…
- 04
Employees engaged in the manufacture and processing of a drug product lack the training required to…
This inspection in context
Laurel A. Beer
14 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in North Carolina.
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 211.160(b)
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 4 observations on this Form 483, mostly about laboratory controls, biologics CGMP and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected FDA Form 483 Janssen, Raritan, NJ Oct 2024?
Laurel A. Beer and Thai D. Truong are named on this Form 483, for the inspection of Dec 5 – Dec 14, 2023. 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 Dec 5 – Dec 14, 2023, and the Form 483 is dated December 14, 2023.
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.