FDA Form 483 Janssen, Raritan, NJ Oct 2024
FDA inspection history in Raritan, New Jersey, 2023 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2023: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–24Two Form 483s, at Raritan, New Jersey.
- 2023The longest 483 on file: 4 observations over 4 pages at Raritan, New Jersey.
Cited most
Across all FDA Form 483 Janssen, Raritan, NJ Oct 2024 observations on file
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.25(a)Personnel qualifications1
- 21 CFR 600.14(a)(1)Reporting of biological product deviations by licensed manufacturers1
The complete FDA Form 483 Janssen, Raritan, NJ Oct 2024 file.
All 2 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
Raritan, New Jersey
Two Form 483s · 2023 to 2024 · 6 observations
Latest: Form 483, Nov 1, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-01 | 483 Form 483 | Raritan, New Jersey | 2 | $99 |
| 2023-12-14 | 483 Form 483 | Raritan, New Jersey | 4 | $99 |
Investigators on these documents
Carl Perez (1)Kevin Matthews (1)Laurel A. Beer (1)Thai D. Truong (1)Xiuju Lu (1)
FEI number 2211100 · most recent document Nov 1, 2024
About FDA Form 483 Janssen, Raritan, NJ Oct 2024
How many FDA Form 483s has FDA Form 483 Janssen, Raritan, NJ Oct 2024 received?
FDA Intel has 2 Form 483s on file for FDA Form 483 Janssen, Raritan, NJ Oct 2024; the most recent is dated Nov 1, 2024.
When was FDA Form 483 Janssen, Raritan, NJ Oct 2024 last inspected by FDA?
The most recent FDA inspection document on file for FDA Form 483 Janssen, Raritan, NJ Oct 2024 is a Form 483 dated Nov 1, 2024, for the site in Raritan, New Jersey.
What did FDA cite at FDA Form 483 Janssen, Raritan, NJ Oct 2024?
The regulations cited most in the observations on file for FDA Form 483 Janssen, Raritan, NJ Oct 2024 are 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.160(b) (General requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time.