Janssen Ortho LLC
FDA inspection history in Gurabo, Puerto Rico, 2009 to 2023
- 9
- Form 483s
Every document, by year
- Form 483
2009: one Form 483; 2011: one Form 483; 2013: one Form 483; 2015: one Form 483; 2016: two Form 483s; 2017: one Form 483; 2018: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2009–18Eight Form 483s, at Gurabo, Puerto Rico.
- 2017The longest 483 on file: 10 observations over 11 pages at Gurabo, Puerto Rico.
- 2023One Form 483, at Gurabo, Puerto Rico.
Cited most
Across all Janssen Ortho observations on file
- 21 CFR 211.160(a)General requirements6
- 21 CFR 211.192Production record review4
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
The complete Janssen Ortho file.
All 9 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Gurabo, Puerto Rico
Nine Form 483s · 2009 to 2023 · 31 observations
Latest: Form 483, Mar 28, 2023 →
Documents
9 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-03-28 | 483 Form 483 | Gurabo, Puerto Rico | 3 | $99 |
| 2018-08-28 | 483 Form 483 | Gurabo, Puerto Rico | 3 | $99 |
| 2017-05-26 | 483 Form 483 | Gurabo, Puerto Rico | 10 | $99 |
| 2016-05-18 | 483 Form 483 | Gurabo, Puerto Rico | 1 | $99 |
| 2016-02-26 | 483 Form 483 | Gurabo, Puerto Rico | 3 | $99 |
| 2015-05-29 | 483 Form 483 | Gurabo, Puerto Rico | 3 | $99 |
| 2013-02-22 | 483 Form 483 | Gurabo, Puerto Rico | 4 | $99 |
| 2011-06-13 | 483 Form 483 | Gurabo, Puerto Rico | 2 | $99 |
| 2009-06-08 | 483 Form 483 | Gurabo, Puerto Rico | 2 | $99 |
Investigators on these documents
Noreen Muniz (2)Laurimer Kuilan-Torres (2)Raquel Gonzalez Rivera (2)Libia M. Lugo (2)Jose E. Melendez (1)Jose Lopez Rubet (1)Ramon A. Hernandez (1)Ariel Cruz Figueroa (1)Vilmary Negron Rodriguez (1)Binh T. Nguyen (1)Dennis Cantellops Paite (1)Jose A. Moreno (1)
FEI number 3002942061 · most recent document Mar 28, 2023
About Janssen Ortho LLC
How many FDA Form 483s has Janssen Ortho LLC received?
FDA Intel has 9 Form 483s on file for Janssen Ortho LLC; the most recent is dated Mar 28, 2023.
When was Janssen Ortho LLC last inspected by FDA?
The most recent FDA inspection document on file for Janssen Ortho LLC is a Form 483 dated Mar 28, 2023, for the site in Gurabo, Puerto Rico.
What did FDA cite at Janssen Ortho LLC?
The regulations cited most in the observations on file for Janssen Ortho LLC are 21 CFR 211.160(a) (General requirements), 6 times; 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.22 (Responsibilities of quality control unit), 4 times.